Clinical trial NCT03658590: Dexamethasone and Induction of Delivery
Official title: Dexamethasone Effect on Induction Delivery Interval at Term Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2018-09-05
Enrollment: 102
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study aims to evaluate the effect of intravenous injection of a single dose of dexamethasone in shortening the duration interval between initiation of labor induction and delivery of the fetus in primigravida full-term pregnancy.

Detailed description: Research hypothesis:

In full term primigravidae undergoing induction of labor, the use of a single dose of dexamethasone (8mg) intra-venously will help in shortening the duration interval between initiation of labor induction and delivery of the fetus.

Research question:

In full term primigravidae undergoing induction of labor, does the use of intra-venous dexamethasone play a role in shortening the duration interval between initiation of labor induction and delivery of the fetus?

Patients and Methods

Type of study:

Double blind randomized controlled trial.

Study settings:

Site: Ain Shams Maternity Hospital Study duration: 6 months

Study population:

One hundred and two pregnant women will be recruited in this study from women attending the emergency room department of obstetrics and gynecology at Ain Shams University.

Inclusion criteria:

Primiparity Singleton pregnancy Gestational age i.e. 40 weeks or more by date or 1st trimestric ultrasound. Bishop score of 4 or greater. Longitudinal lie. Vertex presentation. Intact membranes

Exclusion criteria:

Refused consent Malpresentation. Multiple pregnancies. Active phase of labour. Rupture of membranes (ROM). Cephalo-pelvic disproportion. Previous C-section or myomectomy operation. Known contraindication or hypersensitivity to Dexamethasone. Fetal distress. IUFD Current maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension.

Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound.

Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage.

These criteria will be assessed at first during the initial evaluation in the delivery suite as follows:

History:

Personal, menstrual, obstetric, past and family history will be taken. History of present pregnancy will be taken including the first day of last menstrual period, duration of pregnancy, warning symptoms as headache, visual symptoms, edema of face and fingers, excessive vomiting, heart burn, epigastric pain, vaginal bleeding, decreased fetal movements, edema of the lower limbs and history of any drug intake.

Examination:

1. General examination:vital signs, chest, heart and lower limb examination.
2. Abdominal examination: for assessment of fundal level, presentation, expected fetal weight, fetal heart rate and presence of scars of previous operations as cesarean section or myomectomy.
3. Vaginal examination: for assessment of cervical dilatation and effacement at the beginning, state of fetal membranes, station of fetal head, position of fetal head and pelvic adequacy.

Investigations:

1. Laboratory: blood grouping, Rh typing, complete blood count.
2. Abdominal ultrasound: to confirm the gestational age, fetal number, viability, presentation, position, estimated fetal weight, and to detect the grade of placental maturity, amount and turbidity of liquor.
3. CTG: application of CTG half an hour to all participates before starting any intervention.

Enrollment and Allocation of the patients:

After approval of health ethical committee in Ain Shams Hospital and after the initial evaluation, women who fulfilled the appropriate inclusion and exclusion criteria will be invited to participate in the study, a verbal consent will be obtained from each candidate after explanation of the procedure in details.

Randomization:

The eligible 102 women will be randomized into one of the following two groups:

1. Group D (study group): including 51 women who will receive a prefilled syringe with two milliliters (8 mg) of dexamethasone intravenously.
2. Group P (control group): including 51 women who will receive a prefilled syringe with two milliliters of distilled water intravenously.

No cervical ripping agent will be used for induction of labor in either group. Randomization is performed using a computer-generated randomization system. 102 opaque envelopes will be numbered serially; each envelope will contain the corresponding letter in the randomization table, and when the first pregnant woman arrived, the first envelope will be opened and the pregnant woman will be allocated to the group according to the inside letter.

Eligibility criteria: Inclusion Criteria:

* Primiparity
* Singleton pregnancy
* Gestational age i.e. 40 weeks or more by date or 1sttrimestric ultrasound.
* Bishop score of 4 or greater.
* Longitudinal lie.
* Vertex presentation.
* Intact membranes

Exclusion Criteria:

* Refused consent
* Malpresentation.
* Multiple pregnancies.
* Active phase of labour.
* Rupture of membranes (ROM).
* Cephalo-pelvic disproportion.
* Previous C-section or myomectomy operation.
* Known contraindication or hypersensitivity to Dexamethasone.
* Fetal distress.
* IUFD
* Current maternal disorder e.g. diabetes mellitus and pregnancy induced hypertension.
* Over distended abdomen e.g. fetal macrosomia or polyhydramonus suggested by ultrasound.
* Ante-partum hemorrhage e.g. placenta previa, accidental hemorrhage.

Primary outcomes:
measure: The interval between the initiation of induction and the delivery of the fetus.
timeFrame: Up to 1 day
Secondary outcomes:
measure: The duration of the first stage of labor (Partographic representation will do for each participant).
timeFrame: Up to 1 hour
measure: The duration of the second stage of labor.
timeFrame: Up to 2 hours
measure: The duration of the third stage of labor.
timeFrame: Up to 30 minutes
measure: The neonatal outcome by APGAR score.
timeFrame: at 1 and 5 minutes
measure: Any postpartum maternal adverse effects (e.g. vital sing abnormality, any maternal postpartum hemorrhage and central nervous system manifestation).
timeFrame: Up to 1 day
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
Study officials:
affiliation: Ain Shams University
name: Tarek F Tamara, MD
role: STUDY_CHAIR
affiliation: Ain Shams University
name: Amgad E Abou Gamrah, MD
role: STUDY_DIRECTOR
affiliation: Ain Shams University
name: Gihan E Elhawwary, MD
role: PRINCIPAL_INVESTIGATOR
References: