Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria
Phase: NA
Conditions: Postpartum Hemorrhage (PPH), Postpartum Hemorrhage Third Stage of Labour Retained Placenta
Sponsor: Dangana Zakari Adeka

Study Protocol  |  ABUTHZ/HREC/C08/2017  |  Page 1
STUDY PROTOCOL WITH STATISTICAL ANALYSIS PLAN
Official Title:
Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third
Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital
Zaria
Field
Details
Protocol Version
Version 1.0
Date of Protocol
December 2017
Ethics Approval Number
ABUTHZ/HREC/C08/2017
NHREC Number
NHREC No. 10/12/2015
D-U-N-S Number
D-U-N-S No. 954524802
NCT Number
[To be assigned upon registration]
Sponsor
Ahmadu Bello University Teaching Hospital, Zaria
Principal Investigator
Dr. Dangana Z.A.
Department
Dept. of Obstetrics and Gynaecology, ABUTH, Zaria
Approval Period
14 February 2018 to 14 February 2019
Study Period
February 2018 to August 2019
Document Date
14 February 2018
Confidentiality Statement: This document contains confidential information belonging to Ahmadu
Bello University Teaching Hospital, Zaria. This information is provided to regulatory authorities and
ethics committees for review purposes only.

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TABLE OF CONTENTS
1. Study Synopsis
2. Introduction and Background
3. Study Objectives and Hypotheses
4. Study Design
5. Study Population
6. Interventions
7. Outcome Measures
8. Sample Size Determination
9. Randomization and Blinding
10. Study Procedures
11. Data Collection
12. Statistical Analysis Plan
13. Ethical Considerations
14. Safety Monitoring
15. Study Limitations
16. References

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1. STUDY SYNOPSIS
Field
Description
Full Title
Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management
of Third Stage of Labour: A Study Among Parturients at Ahmadu Bello
University Teaching Hospital Zaria
Study Design
Randomized, double-blind (triple masking), placebo-controlled, parallel-group
clinical trial
Phase
Not Applicable (licensed drug, alternative route)
Primary Purpose
Treatment
Condition
Postpartum haemorrhage; Third stage of labour; Retained placenta
Intervention
Intra-umbilical vein injection of 20 IU oxytocin diluted in 18 ml normal saline
(total 20 ml) vs. 20 ml plain normal saline (placebo)
Sample Size
416 (207 oxytocin group; 209 placebo group)
Primary Outcomes
1. Postpartum blood loss (drape weight method, within 1 hour)
2. Duration of third stage of labour (stopwatch)
3. Change in maternal haemoglobin (labour vs. 24 hours postpartum)
Study Site
Labour and Postnatal Wards, Ahmadu Bello University Teaching Hospital,
Shika-Zaria, Kaduna State, Nigeria
Study Duration
February 2018 to August 2019
Sponsor
Ahmadu Bello University Teaching Hospital, Zaria
Principal Investigator
Dr. Dangana Z.A., Department of Obstetrics and Gynaecology
Ethics Approval
ABUTHZ/HREC/C08/2017; Approved 20 December 2017

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2. INTRODUCTION AND BACKGROUND
Postpartum haemorrhage (PPH) remains one of the leading causes of maternal morbidity and
mortality worldwide, accounting for approximately 25% of all maternal deaths. The majority of these
deaths occur during the third stage of labour, the period between delivery of the baby and expulsion
of the placenta. In sub-Saharan Africa, the maternal mortality ratio remains disproportionately high,
and haemorrhage is the leading direct cause.
Active management of the third stage of labour (AMTSL) with intramuscular oxytocin and controlled
cord traction is the current standard of care and has been shown to reduce postpartum blood loss.
However, in settings where access to blood transfusion and advanced obstetric care is limited,
additional low-cost interventions that can further reduce blood loss are needed.
Oxytocin administered directly through the umbilical vein reaches the placental bed via retrograde
flow, potentially enhancing localised uterine contraction at the site of placental attachment. This
targeted approach may shorten the duration of the third stage of labour, reduce the volume of
postpartum blood loss, and help preserve maternal haemoglobin. The procedure is simple,
inexpensive, and can be performed by trained nurses and midwives.
Umbilical vein injection for the management of retained placenta was first described by Mojon and
Asdrubali in 1826. Recent studies from Turkey, Iran, and the United States have evaluated
intra-umbilical oxytocin as an adjunct to AMTSL with varying results. A meta-analysis concluded that
routine use of umbilical vein injection of oxytocin is not recommended until new evidence becomes
available. This study was designed to contribute such evidence.

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3. STUDY OBJECTIVES AND HYPOTHESES
3.1 General Aim
To determine the effect of umbilical vein injection of oxytocin on the third stage of labour when
administered in conjunction with active management of the third stage of labour.
3.2 Specific Objectives
• To determine the effect of intra-umbilical vein injection of oxytocin on postpartum blood loss
• To estimate the effect of intra-umbilical vein injection of oxytocin on the duration of the third
stage of labour
• To measure the effect of intra-umbilical vein injection of oxytocin on postpartum haemoglobin
change
3.3 Hypotheses
Null hypothesis: Umbilical vein injection of oxytocin has no effect on the outcome of the third stage
of labour.
Alternative hypothesis: Umbilical vein injection of oxytocin has a significant effect on the outcome
of the third stage of labour.
4. STUDY DESIGN
This was a randomized, double-blind (triple masking: participant, investigator, outcomes assessor),
placebo-controlled, parallel-group clinical trial conducted at the labour and postnatal wards of
Ahmadu Bello University Teaching Hospital (ABUTH), Shika-Zaria, Kaduna State, Nigeria.
ABUTH Shika-Zaria is a tertiary institution with approximately 3,000 deliveries annually. Zaria is a
heterogeneous city in Kaduna State inhabited by approximately 975,228 people, located on the high
plains of northern Nigeria at 675 metres above sea level.
Design Element
Description
Study Type
Interventional
Study Model
Parallel Assignment
Number of Arms
2
Allocation
Randomized
Masking
Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose
Treatment
Phase
Not Applicable
Enrollment
416 (Actual)

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5. STUDY POPULATION
The study population comprised consecutive, eligible, and consenting parturients undergoing
vaginal delivery at the labour ward of ABUTH Shika-Zaria.
5.1 Inclusion Criteria
• Pregnant women aged 18 to 35 years
• Singleton live pregnancy
• Gestational age between 37 and 42 weeks
• Vaginal delivery
• Parity between 1 and 4
• Haemoglobin concentration of 10 g/dl or higher before delivery
• No identifiable risk factors for postpartum haemorrhage
• Willing and able to provide written informed consent
5.2 Exclusion Criteria
• Blood pressure of 140/90 mmHg or higher
• Placenta praevia
• Placental abruption
• History of vaginal bleeding in the index pregnancy
• Previous caesarean section or any uterine scar
• Coagulation disorders
• Instrumental delivery
• Haemoglobin concentration below 10 g/dl
• Multiple gestation
• Fibroids coexisting with pregnancy
• Genital tract lacerations or bleeding episiotomy
6. INTERVENTIONS
Both groups received routine active management of the third stage of labour (AMTSL), which
consisted of intramuscular injection of 10 international units of oxytocin within one minute of delivery
and controlled cord traction. The intra-umbilical vein injection was administered approximately one
minute following the intramuscular oxytocin injection.
6.1 Arm 1: Oxytocin Group (Active Comparator)
Participants received an intra-umbilical vein injection of 20 international units (IU) of oxytocin
(Syntocinon) diluted in 18 ml of normal saline to a total volume of 20 ml. The injection was
administered immediately after delivery of the baby and cord clamping using a 20 ml syringe with an
18-gauge needle. The umbilical vein was identified as the largest and most centrally positioned of
the three umbilical vessels. The solution was injected slowly over approximately 30 seconds at a
point 2 to 3 cm from the introitus. A clamp was then applied below the injection site to prevent
spillage, and the cord was milked towards the placenta, followed by controlled cord traction.
6.2 Arm 2: Normal Saline Group (Placebo Comparator)
Participants received an intra-umbilical vein injection of 20 ml of plain normal saline. The injection
was identical in volume, route, and method of administration to the oxytocin intervention but

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contained no active drug. This served as the placebo comparator. The same injection technique,
timing, and subsequent procedures (clamping and cord traction) were followed as in the oxytocin
group.
Feature
Oxytocin Group
Normal Saline Group
Arm Type
Active Comparator
Placebo Comparator
Intervention Type
Drug
Other
Intervention Name
Oxytocin
Normal Saline Placebo
Solution Content
20 IU oxytocin in 18 ml NS (total 20
ml)
20 ml plain normal saline
Route
Intra-umbilical vein injection
Intra-umbilical vein injection
Number Analysed
207
209
Background AMTSL
IM oxytocin 10 IU + CCT
IM oxytocin 10 IU + CCT

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7. OUTCOME MEASURES
7.1 Primary Outcome Measures
Outcome
Measurement Method
Time Frame
1. Postpartum blood
loss
Blood collected using a Nightingale drape placed
under the parturient immediately after delivery. The
drape was weighed before and after use; the
difference in weight (grams) was taken as equivalent
to blood loss in millilitres.
Within 
1 
hour 
after
delivery
2. Duration of third
stage of labour
Time 
measured 
using 
a 
stopwatch 
started
immediately after delivery of the baby and stopped
upon complete expulsion of the placenta.
From delivery of baby to
delivery of placenta
3. 
Change 
in
maternal
haemoglobin
Haemoglobin concentration measured during labour
and at 24 hours postpartum using standard laboratory
methods. 
The 
difference 
was 
calculated 
and
expressed in g/dl.
From labour to 24 hours
postpartum
7.2 Additional Outcomes Assessed
• Incidence of postpartum haemorrhage (blood loss of 500 ml or more)
• Percentage of placentae remaining undelivered beyond 15 minutes
• Incidence of retained placenta (placenta not delivered within 30 minutes)
• Need for blood transfusion
8. SAMPLE SIZE DETERMINATION
The sample size was calculated using the formula for clinical trial studies:
n = D [Za + Zb]2 x [(P1 x (1 - P1)) + (P2 x (1 - P2))] / (P2 - P1)2
Where:
• n = required minimum sample size per comparison group
• D = design effect (assumed to be 2)
• Za = Z score corresponding to 95% level of significance = 1.96
• Zb = Z score corresponding to 80% statistical power = 0.84
• P1 = proportion with PPH in control group from a previous study = 4% (0.04)
• P2 = proportion with PPH in experimental group from same study = 0% (0.00)
The calculated minimum sample size was 188 per group. With a 10% attrition allowance (19
participants), the total required was 207 per group, rounded up to 210 per group (total enrollment
target: 420). The software WINPEPI version 2.80 was used to generate random numbers for
allocation.
9. RANDOMIZATION AND BLINDING
9.1 Randomization

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Randomization was performed using computer-generated random numbers (WINPEPI version
2.80). Numbers 001 to 460 were generated and assigned to either the intervention or control group.
Each number was printed on a paper, which was stapled, folded, and placed in an opaque sealed
envelope. The envelopes were spread in a tray. Each eligible consenting parturient picked one
envelope, which was handed to a trained nurse for allocation.
9.2 Blinding (Masking)
Triple masking was employed (Participant, Investigator, Outcomes Assessor). The trained nurse
who received the envelope secretly opened it to determine group allocation. She then secretly
prepared the assigned solution: either 20 IU oxytocin in 18 ml normal saline or 20 ml plain normal
saline. Both solutions were identical in volume (20 ml) and were labelled only as 'for intra-umbilical
vein injection,' ensuring that participants and the administering clinician could not distinguish
between them.
The primary investigator responsible for measuring all outcome variables (postpartum blood loss,
duration of third stage of labour, and haemoglobin change) was blinded to group assignment
throughout data collection. Group allocation was disclosed to the investigator only after all outcome
measures had been recorded for each participant.

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10. STUDY PROCEDURES
10.1 Recruitment
The primary investigator provided education about the study at the antenatal clinic as a form of
group counselling. When eligible parturients presented in labour, a brief history was taken and
examinations were conducted by a trained registrar or senior registrar. Written informed consent
was obtained from all eligible participants.
10.2 Delivery and Intervention
• After delivery of the baby, the umbilical cord was clamped in two places and cut between the
clamps to separate the baby.
• Intramuscular oxytocin (10 IU) was administered within one minute of delivery as part of
routine AMTSL.
• The pre-prepared intra-umbilical vein injection was administered by a trained registrar or
senior registrar using a 20 ml syringe with an 18-gauge needle.
• The umbilical vein was identified as the largest and most centrally positioned of the three
umbilical vessels.
• The solution was injected slowly over approximately 30 seconds at a point 2 to 3 cm from the
introitus.
• A clamp was applied just below the injection site to prevent spillage of the injected solution.
• The cord was milked towards the placenta, followed by controlled cord traction.
• The placenta was considered retained if it could not be delivered within 30 minutes of delivery.
10.3 Blood Loss Measurement
Immediately after delivery, any liquor on the mackintosh was cleaned. A pre-weighed Nightingale
drape was placed under the parturient to collect postpartum blood for one hour. The drape was
weighed after collection, and the difference in weight (grams) was taken as equivalent to blood loss
in millilitres.
10.4 Duration of Third Stage
A stopwatch was started immediately upon delivery of the baby and stopped upon complete delivery
of the placenta. The elapsed time was recorded as the duration of the third stage of labour in
minutes.
10.5 Haemoglobin Estimation
Haemoglobin concentration was measured during labour and again at 24 hours postpartum using
standard laboratory methods. The difference between the two measurements was calculated and
recorded as the postpartum haemoglobin change (g/dl).
11. DATA COLLECTION
The following baseline characteristics were collected for all participants:
• Maternal age (years)
• Gestational age at labour (weeks)
• Parity
• Use of oxytocin during labour (augmentation)

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• Baby birth weight (kg)
• Haemoglobin concentration in labour (g/dl)
• Haemoglobin concentration 24 hours postpartum (g/dl)
Data were recorded on a structured proforma and subsequently entered into a computerised
database for analysis.

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12. STATISTICAL ANALYSIS PLAN
All statistical analyses were performed using the Statistical Package for Social Sciences version 25
(SPSS 25, IBM Corporation, Armonk, NY, USA).
12.1 Descriptive Statistics
Continuous variables were summarised as mean and standard deviation (SD). Categorical variables
were expressed as frequencies and percentages. Baseline characteristics of the two groups were
compared to confirm the adequacy of randomization.
12.2 Comparison of Groups
Comparison of the two groups regarding the duration of the third stage of labour, postpartum blood
loss, haemoglobin change, and other continuous variables was performed using the independent
samples Student's t-test after assessment of equality of variances and homogeneity using Levene's
test.
Categorical variables (e.g., incidence of PPH, retained placenta) were compared between the two
groups using the chi-squared test.
12.3 Level of Significance
A p-value of less than 0.05 was considered statistically significant for all analyses. Results are
presented with 95% confidence intervals where appropriate.
12.4 Analysis Population
Analysis was performed on a per-protocol basis. Participants who were randomized but
subsequently excluded due to caesarean section (n=18), instrumental delivery (n=4), bleeding
genital lacerations (n=8), or absence of trained personnel to administer the injection (n=14) were
excluded from the final analysis. A total of 416 participants (207 oxytocin group, 209 placebo group)
were included in the final analysis.
12.5 Handling of Missing Data
Participants with incomplete outcome data were excluded from the analysis of the relevant outcome
measure. No imputation of missing data was planned.
Analysis
Variable
Statistical Test
Primary
Postpartum blood loss (ml)
Independent t-test
Primary
Duration of third stage (min)
Independent t-test
Primary
Haemoglobin change (g/dl)
Independent t-test
Secondary
Incidence of PPH
Chi-squared test
Secondary
Placenta undelivered >15 min
Chi-squared test
Baseline
Maternal age, GA, parity, birth weight
Independent t-test / chi-squared
Variance
Equality of variances
Levene's test

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13. ETHICAL CONSIDERATIONS
Ethical clearance was obtained from the Health Research Ethics Committee (HREC) of Ahmadu
Bello University Teaching Hospital, Zaria.
Item
Details
Ethics Committee
ABUTH Health Research Ethics Committee (HREC)
Approval Number
ABUTHZ/HREC/C08/2017
NHREC Registration
NHREC No. 10/12/2015
D-U-N-S Number
954524802
Date of Approval
20 December 2017
Approval Period
14 February 2018 to 14 February 2019
The study was conducted in compliance with the Declaration of Helsinki. Written informed consent
was obtained from all participants prior to enrolment. Participants were informed of the nature,
purpose, and potential benefits of the study. All participants received free haematinics as a benefit
of participation.
Participation was voluntary, and parturients were free to withdraw from the study at any time without
any impact on their clinical care. Confidentiality of all participant data was maintained throughout the
study.
14. SAFETY MONITORING
The intra-umbilical vein injection of oxytocin is considered a low-risk intervention. Oxytocin is a
licensed uterotonic drug already administered intramuscularly as part of routine AMTSL. The
umbilical vein injection delivers the drug locally to the placental bed with minimal systemic
absorption.
All participants were monitored postpartum according to routine institutional protocols. Any adverse
events, including excessive blood loss requiring transfusion, retained placenta requiring manual
removal, or other complications, were documented and managed according to standard clinical
practice. The primary investigator was responsible for safety oversight throughout the study period.
15. STUDY LIMITATIONS
Parturients with risk factors for postpartum haemorrhage, in whom the effect of umbilical vein
injection of oxytocin might have been more clearly demonstrated, were excluded from the study.
This was a single-centre study, which may limit the generalizability of the findings to other settings.
16. REFERENCES
1. Güngördük K, Asicioglu O, Besimoglu B, et al. Using intraumbilical vein injection of oxytocin in
routine practice with active management of the third stage of labor: a randomized controlled trial.
Obstet Gynecol. 2010;116(3):619-624.
2. Weeks AD, Alia G, Vernon G, et al. Umbilical vein oxytocin for the treatment of retained placenta
(Release Study): a double-blind, randomised controlled trial. Lancet. 2010;375(9709):141-147.

Study Protocol  |  ABUTHZ/HREC/C08/2017  |  Page 14
3. Say L, Chou D, Gemmill A, et al. Global causes of maternal death: a WHO systematic analysis.
Lancet Glob Health. 2014;2(6):e323-e333.
4. WHO. Maternal mortality fact sheet. World Health Organization; 2016.
5. Begley CM, Gyte GML, Devane D, et al. Active versus expectant management for women in the
third stage of labour. Cochrane Database Syst Rev. 2019;(2):CD007412.
6. Weeks AD. The retained placenta. Afr Health Sci. 2001;1(1):36-41.
7. Soltani H, Poulose TA, Hutchon DR. Placental cord drainage after vaginal delivery as part of the
management of the third stage of labour. Cochrane Database Syst Rev. 2011;(9):CD004665.
8. WHO. WHO recommendations for the prevention and treatment of postpartum haemorrhage.
Geneva: World Health Organization; 2012.

Informed Consent Form  |  ABUTHZ/HREC/C08/2017  |  Page 1
INFORMED CONSENT FORM
Official Title:
Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third
Stage of Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital
Zaria
Field
Details
Ethics Approval Number
ABUTHZ/HREC/C08/2017
NHREC Number
NHREC No. 10/12/2015
NCT Number
[To be assigned upon registration]
Principal Investigator
Dr. Dangana Z.A.
Department
Dept. of Obstetrics and Gynaecology, ABUTH, Zaria
Institution
Ahmadu Bello University Teaching Hospital, Shika-Zaria
Date of Approval
20 December 2017
Approval Period
14 February 2018 to 14 February 2019
Document Date
14 February 2018
This Informed Consent Form has been reviewed and approved by the Health Research Ethics
Committee (HREC) of Ahmadu Bello University Teaching Hospital, Zaria.

Informed Consent Form  |  ABUTHZ/HREC/C08/2017  |  Page 2
AHMADU BELLO UNIVERSITY TEACHING HOSPITAL, ZARIA
DEPARTMENT OF OBSTETRICS AND GYNAECOLOGY
INFORMED CONSENT FORM FOR RESEARCH PARTICIPATION
Ethics Approval Number: ABUTHZ/HREC/C08/2017
TITLE OF STUDY
Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of
Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria.
INTRODUCTION
You are being asked to take part in a research study. Before you decide whether to participate, it is
important for you to understand why the research is being done and what it will involve. Please take
time to read the following information carefully. Ask questions if anything is not clear or if you would
like more information. Take time to decide whether or not you wish to participate.
PURPOSE OF THE STUDY
Bleeding after delivery of a baby is a serious problem that can affect the health of mothers,
especially in our environment. The third stage of labour is the period between the birth of the baby
and the delivery of the afterbirth (placenta). During this time, some women may bleed heavily.
Currently, all women who deliver in our hospital receive an injection of a medicine called oxytocin
into the thigh muscle immediately after delivery, along with gentle pulling on the cord. This is the
standard way of managing the third stage of labour and helps to reduce bleeding.
This study aims to find out whether giving an additional injection of oxytocin through the cord of the
afterbirth (umbilical vein) can further help to reduce bleeding, shorten the time it takes for the
afterbirth to come out, and preserve the level of blood in your body.
WHAT WILL HAPPEN IF YOU TAKE PART
If you agree to participate, the following will happen:
• You will be placed into one of two groups by chance (like flipping a coin). This is called
randomization. Neither you nor the doctor measuring the results will know which group you are
in until after the study.
• Group 1 (Oxytocin Group): After your baby is born and the cord is cut, you will receive an
injection of oxytocin medicine (20 units) mixed with salt water through the cord leading to the
afterbirth. This is in addition to the routine injection you will receive in your thigh.
• Group 2 (Salt Water Group): After your baby is born and the cord is cut, you will receive an
injection of plain salt water (which contains no medicine) through the cord leading to the
afterbirth. This is in addition to the routine injection you will receive in your thigh.
• A special cloth (drape) will be placed under your buttocks after delivery to collect and measure
any blood lost.
• A blood test will be done during your labour and again 24 hours after delivery to check your
blood level (haemoglobin).
• The time it takes for the afterbirth to deliver will be measured.
• All other aspects of your care during and after delivery will follow standard hospital practice.
POSSIBLE RISKS AND DISCOMFORTS

Informed Consent Form  |  ABUTHZ/HREC/C08/2017  |  Page 3
The injection through the cord of the afterbirth is given after the baby has already been separated,
so there is no risk to your baby. Oxytocin is a medicine that is already routinely used in the
management of labour and delivery. The procedure of injecting through the umbilical vein is simple
and is not expected to cause you any additional pain or discomfort beyond what is experienced
during normal delivery.
The blood tests require a small needle prick, which may cause brief discomfort.
POSSIBLE BENEFITS
If the additional injection of oxytocin through the umbilical vein is effective, it may help to reduce the
amount of blood you lose after delivery, shorten the time it takes for the afterbirth to come out, and
help maintain your blood level. This may reduce the likelihood of needing a blood transfusion. Even
if you do not benefit directly, the information gathered from this study may help other women in the
future.
All participants will receive free blood-building tablets (haematinics) as a benefit of participation.
ALTERNATIVES TO PARTICIPATION
If you choose not to participate in this study, you will receive the standard management of the third
stage of labour as practiced in this hospital, which includes the routine intramuscular injection of
oxytocin and controlled cord traction. Your decision not to participate will not affect your care in any
way.
CONFIDENTIALITY
All information collected about you during the course of this study will be kept strictly confidential.
You will be identified only by a study number, and your personal details will not be disclosed in any
publication or report arising from this study. Only the research team will have access to your
records. Data will be stored securely and handled in accordance with the requirements of the Health
Research Ethics Committee of ABUTH.
VOLUNTARY PARTICIPATION AND WITHDRAWAL
Your participation in this study is entirely voluntary. You are free to decline to participate or to
withdraw from the study at any time, without giving any reason. Your decision to participate or not
will not affect the quality of care you receive at this hospital. If you withdraw, any data collected up to
the point of withdrawal may still be used in the analysis unless you request otherwise.
COMPENSATION
There is no financial compensation for participating in this study. However, all participants will
receive free haematinics (blood-building tablets).
CONTACT INFORMATION
If you have any questions about this study, your rights as a participant, or if you experience any
problems related to the study, please contact:
Principal Investigator: Dr. Dangana Z.A.
Department: Obstetrics and Gynaecology, ABUTH, Zaria
Email: drdangiza@gmail.com
If you have concerns about the conduct of this study or your rights as a research participant, you
may contact:

Informed Consent Form  |  ABUTHZ/HREC/C08/2017  |  Page 4
Health Research Ethics Committee (HREC)
Ahmadu Bello University Teaching Hospital, Shika-Zaria
Email: aaborethrec@yahoo.com

Informed Consent Form  |  ABUTHZ/HREC/C08/2017  |  Page 5
AHMADU BELLO UNIVERSITY TEACHING HOSPITAL, ZARIA
CONSENT DECLARATION
Ethics Approval Number: ABUTHZ/HREC/C08/2017
I have read and understood the information provided above about the study titled:
"Effect of Umbilical Vein Injection of Oxytocin in Addition to Active Management of Third Stage of
Labour: A Study Among Parturients at Ahmadu Bello University Teaching Hospital Zaria."
• I have been given the opportunity to ask questions and my questions have been answered to
my satisfaction.
• I understand that my participation is voluntary and that I am free to withdraw at any time
without giving any reason and without my medical care or legal rights being affected.
• I understand that relevant sections of my medical records and data collected during this study
may be looked at by the research team.
• I understand that my identity will be kept confidential and that I will not be identified in any
publication arising from this study.
• I understand that I will receive free haematinics as a benefit of my participation.
• I agree to participate in this study.
__________________________________________
Name of Participant
__________________________________________ __________________
Signature / Thumbprint of Participant Date
__________________________________________
Name of Witness (if participant cannot read or write)
__________________________________________ __________________
Signature of Witness Date
__________________________________________
Name of Person Obtaining Consent
__________________________________________ __________________
Signature of Person Obtaining Consent Date
One copy of this form will be given to the participant and one copy will be retained by the research team.