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Trial · Interventional

CompletedPhase 4Registry data

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

Short name MOLI

NCTNCT03749902 (opens ClinicalTrials.gov in a new tab)Other id4007
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
520 participants (actual)
Sponsor
University of Liverpool · Other
Design
Randomized · Open label (no masking)
Countries
1 country

India

Start
6 Jan 2020
Primary completion
30 Jul 2022
Completion
30 Jul 2022
First posted
21 Nov 2018
Last update posted
18 Dec 2024
Conditions
Induction of Labor

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2020202120222023
  1. Ph 4

    MOLI

    NCT03749902

    6 Jan 2020 to 30 Jul 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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?

Interventions

  • Oral misoprostolDrug
  • OxytocinDrug

Arms2

  • Other

    Oxytocin infusion

    * 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

    Oral misoprostol

    * 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Caesarean birth

    Time frame · At delivery

    Registry description

    Rate of caesarean birth in the treatment arm

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

0 studies on this page

Indexing hint: Randomized controlled trial · 2023

Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool.

Symon et al. 2023BMC medical research methodologycited by 4

PMID 37759174PMC10537543DOI 10.1186/s12874-023-02016-1PUB-37759174

CC BY
Download PDF

More studies

2 studies on this page

Indexing hint: Randomized controlled trial · 2025

Evaluating women's experiences and satisfaction with labour induction in India: a comparison of the participant generated experience and satisfaction (PaGES) index with standard methods.

Patel et al. 2025BMC pregnancy and childbirth

PMID 40437451PMC12117871DOI 10.1186/s12884-025-07731-9PUB-40437451

CC BY
Download PDF

Indexing hint: Clinical trial · 2021

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.

Bracken et al. 2021BMC pregnancy and childbirthcited by 7

PMID 34325670PMC8320158DOI 10.1186/s12884-021-04009-8PUB-34325670

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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)

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