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NCT Number: NCT03749902

A Randomized Trial of Oral Misoprostol Alone Versus Oral Misoprostol Followed by Oxytocin for Labour Induction

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?

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Key information

Conditions

Induction of Labor Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pre-Eclampsia Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Daga Memorial Women's Hospital, Nagpur, Maharashtra, India

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Oral misoprostol

Drug
  • An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose).
  • The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes)
  • If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted
  • In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency.

Other names: Misoprost

Oxytocin

Drug
  • Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics.
  • The oxytocin group will not receive misoprostol after the membranes have ruptured.

Other names: Pitocin

Primary outcomes

  1. Caesarean birth

    Time frame: At delivery

    Rate of caesarean birth in the treatment arm

Sponsors and collaborators

Lead sponsor

University of Liverpool

Other

Collaborators

  • Daga Memorial Women's Hospital, Nagpur, India
  • Government Medical College, Nagpur
  • Gynuity Health Projects
  • Mahatma Gandhi Institute of Medical Sciences

Registry information

Official study title

A Randomized Trial Comparing Oral Misoprostol Alone with Oral Misoprostol Followed by Oxytocin in Women Induced for Hypertension of Pregnancy

Acronym: MOLI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 21, 2018
Registry last updated
Dec 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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