Clinical trial NCT02223806: Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
Official title: Active Management of the Third Stage of Labour: Uterine Tonus Assessment by Midwife vs. Patient Self-administration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Hemorrhage
Keywords: Postpartum hemorrhage
Uterine tonus assessment
Active management of third stage of labor
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Korle-Bu Teaching Hospital, Accra, Ghana
name: University of Ghana
First posted: 2014-08-22
Enrollment: 800
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage, mean blood loss, and other maternal and neonatal outcomes.

Detailed description: Rationale: Postpartum haemorrhage (PPH) is the most common cause of maternal death worldwide. The active management of the third stage of labour (AMTSL) is recognized as an effective strategy to prevent morbidity and mortality associated with PPH and reduce blood loss. AMTSL includes the provision of uterotonic drugs, controlled cord traction, delayed cord clamping and cutting, massage of the uterus, and monitoring of the uterine tonus. Although professional guidelines recommend the steps of AMTSL to be performed by health professionals, the reality of health professionals understaffed hospitals in many low- and middle income countries (LMICs) necessitates task-shifting of the final AMTSL component to patients. Yet, whether uterine tonus assessment yields the same effect when performed by patients and midwives has not been formally evaluated.

Objective: To determine whether there is a difference in effectiveness of routine uterine tonus assessment (every 15 minutes, for 2 hours) when performed by a midwife or self-administered by a patient on the incidence of postpartum haemorrhage . mean blood loss, and other maternal and neonatal outcomes.

Study design: Randomized intervention study. Study population: Pregnant women admitted in the labour to the Korle Bu Teaching Hospital, Accra, Ghana Intervention: the intervention group will receive uterine tonus assessment every 15 minutes for 2 hours by a midwife, the control group will continue the current practice of self-assessment after patient education with regular monitoring of midwives.

Main study parameters/endpoints: post-partum haemorrhage (\>500 ml blood loss), severe postpartum haemorrhage (\>1000 ml blood loss), mean blood loss, other maternal and neonatal outcomes.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will receive the standard of midwifery and obstetric care, and will have access to emergency obstetric interventions. All steps of the AMTSL will be performed, with the exemption of the last step of uterine tonus assessment for which women will be randomized to receive the intervention or current practice of care. Risk associated with the intervention are discomfort because of an external assessment. Data will be obtained from record books at the ward. Women will be asked for informed consent prior to participation. This study will be approved by the Ethical en Protocol Review Committee of the University of Ghana Medical School and the Medical Ethical Research Committee of the University Medical Center Utrecht.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Be in labor with an expected vaginal delivery, as assessed by the midwives
* Gestation age ≥ 37 weeks
* Received antenatal instructions on postnatal uterine tonus assessment
* Provided informed consent.

Exclusion Criteria:

* Age \<18
* Elective caesarean delivery
* Severe anemia (\<8g/dL)
* Placenta praevia
* Anticipated breech delivery
* Referred patients who have not received antenatal care (ANC) uterine tonus assessment instructions
* Multiple Pregnancy
* Intra uterine fetal death

Primary outcomes:
measure: Postpartum hemorrhage (>500 ml blood loss)
timeFrame: within 24 hours postpartum
Secondary outcomes:
measure: Mean blood loss (in ml)
timeFrame: Within 24 hours postpartum
measure: Severe post-partum hemorrhage
timeFrame: Within 24 hours postpartum
measure: Use of additional uterotonics
timeFrame: Within 24 hours postpartum
measure: Use of other procedures for management of postpartum hemorrhage
timeFrame: Within 24 hours postpartum
measure: Late postpartum hemorrhage
timeFrame: From 24 hours and upto one week
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Korle Bu Teaching Hospital
Study officials:
affiliation: UMC Utrecht, the Netherlands
name: Joyce L Browne, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Utrecht, The Netherlands
name: Kerstin D Klipstein-Grobusch, PhD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Korle-Bu Teaching Hospital, Accra, Ghana
name: Nelson Damale, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Browne JL, Damale NK, Raams TM, Van der Linden EL, Maya ET, Doe R, Rijken MJ, Adanu R, Grobbee DE, Franx A, Klipstein-Grobusch K. Uterine Tonus Assessment by Midwives versus Patient self-assessment in the active management of the third stage of labor (UTAMP): study protocol for a randomized controlled trial. Trials. 2015 Dec 18;16:580. doi: 10.1186/s13063-015-1111-5.