The objective of our study is to investigate whether the use
of obstetric gel shortens the first and second stage of labor and exerts a
protective effect on the lower genital tract. Neonatal and maternal morbidities
will be also assessed.
The study design will be a randomized controlled trial of 2 groups, where the patients presenting for vaginal delivery will be randomly assigned to either:
- Group 1 who will receive the standard care during labor and delivery
- Group 2 who will receive the standard care during labor and delivery with the vaginal application of the obstetrical gel
All eligible women followed up at the Women’s Health Center
and the Outpatient clinics at AUBMC who meet the inclusion criteria will be
invited to participate in the study.
They will be approached by the research assistant who will
explain the objectives of the study in one of the new nursing assessment rooms
at the Women’s Health Center without needing to use any paramedical devices
(Blood pressure machine, scale, etc….); and will ask eligible women to
participate in the trial after explaining to them all the details of the study
and the specifications of the gel (as by the proposal and included in the
consent) and sign a consent form.
Upon admission to Dr. Khaled Idriss Delivery Suite,
recruited women will be randomized using cluster randomization process. The
clustering will be considered according to being nulliparas or multiparas
groups. Accordingly, two
computer-generated random number sequences, one for each group will be
developed, with a 1:1 ratio. At the time of the admission, a sealed opaque
envelope containing the randomization number and data sheet will be opened by
the PGYII resident for each consenting woman. As a
result of the nature of the intervention, neither participants nor research
staff will be blinded to group allocation.
- Age between 18 and 40 years
- Intended vaginal delivery
- Singleton baby in vertex presentation
- Low risk pregnancy at term (37–42 weeks of gestation)
- Estimated birth weight between 2000 g and 4500 g (clinically or by sonography)
-
Signed written informed consent
- Contraindications for vaginal delivery (placenta previa, active herpes infection, etc…)
- Advanced cervical dilation (≥ 5 cm)
- Suspected amniotic infection (fever, foul smelling discharge, fetal tachycardia, abdominal pain)
- Non reassuring fetal heart tracing
- Prolonged rupture of the membranes (24 hours)
- Suspected major fetal malformations
-
Suspected cephalopelvic disproportion