Clinical trial NCT03749902: A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction
Official title: A Randomized Trial Comparing Oral Misoprostol Alone with Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Induction of Labor
Keywords: preeclampsia
misoprostol
oxytocin
Lead sponsor: University of Liverpool
Sponsor class: OTHER
Collaborators: name: Gynuity Health Projects
name: Government Medical College, Nagpur
name: Daga Memorial Women's Hospital, Nagpur, India
name: Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India
First posted: 2018-11-21
Enrollment: 520
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the trial is to assess the following: In women who have undergone cervical preparation with oral misoprostol as part of labour induction for hypertensive disease in India, is augmentation using oral misoprostol superior to the standard protocol of intravenous oxytocin?

Detailed description: Every year approximately 30 000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion. However, some studies have shown that oral misoprostol can be continued into active labour. In the Cochrane review on labour induction, those whose augmentation was continued with misoprostol (M/M protocol) had 42% less CSs than those who changed to oxytocin (M/Ox protocol; 15% vs 26%). This misoprostol-only protocol would be simpler and probably more acceptable to women. However, these two protocols have never been directly compared. We propose a pragmatic, open-label, randomised trial to compare an M/M labour induction protocol with the standard M/Ox protocol.

Eligibility criteria: Inclusion Criteria:

* • Ongoing pregnancies with a live fetus who require induction because of preeclampsia or hypertensionWomen will be included irrespective of whether an intrapartum caesarean birth on fetal grounds would be considered or not

  * Women age ≥18 years
  * Signed informed consent form
  * Undergone cervical ripening with misoprostol if cervix initially unfavourable
  * Decision to augment labour for inadequate uterine contractions despite ruptured membranes (either artificial or spontaneous as part of the induction process)s

Exclusion Criteria:

* Women with previous caesarean births
* Those unable to give informed consent
* Cervical ripening with agents other than misoprostol (e.g. Foley catheter, prostaglandins)
* Multiple pregnancy
* History of allergy to misoprostol
* Adequate uterine activity
* Pre- induction Ruptured amniotic membranes
* Frank chorioamnionitis (systemic illness with purulent vaginal discharge and uterine tenderness)

Primary outcomes:
measure: Caesarean birth
timeFrame: At delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Memorial Women's Hospital
state: Maharashtra
city: Sevagram
country: India
facility: Mahatma Gandhi Institute of Medical Sciences
state: Maharashtra
city: Nagpur
country: India
facility: Government Medical College (GMC)
Study officials:
affiliation: University of Liverpool
name: Andrew D Weeks, FRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bracken H, Lightly K, Mundle S, Kerr R, Faragher B, Easterling T, Leigh S, Turner M, Alfirevic Z, Winikoff B, Weeks A. Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial. BMC Pregnancy Childbirth. 2021 Jul 29;21(1):537. doi: 10.1186/s12884-021-04009-8.