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

NCT ID: NCT03749902

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

520 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-06

Study Completion Date

2022-07-30

Brief Summary

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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

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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.

Conditions

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Induction of Labor

Keywords

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preeclampsia misoprostol oxytocin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Oxytocin

Intervention Type 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.

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.

Group Type OTHER

Oral misoprostol

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Oxytocin

* 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.

Intervention Type DRUG

Other Intervention Names

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Misoprost Pitocin

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Gynuity Health Projects

OTHER

Sponsor Role collaborator

Government Medical College, Nagpur

INDUSTRY

Sponsor Role collaborator

Daga Memorial Women's Hospital, Nagpur, India

OTHER

Sponsor Role collaborator

Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India

UNKNOWN

Sponsor Role collaborator

University of Liverpool

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew D Weeks, FRCOG

Role: PRINCIPAL_INVESTIGATOR

University of Liverpool

Locations

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Daga Memorial Women's Hospital

Nagpur, Maharashtra, India

Site Status

Mahatma Gandhi Institute of Medical Sciences

Sevāgrām, Maharashtra, India

Site Status

Government Medical College (GMC)

Nagpur, , India

Site Status

Countries

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India

References

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Patel A, Howard R, Faragher B, Durocher J, Winikoff B, Symon A, Weeks A, Mundle S, Lightly K. 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. BMC Pregnancy Childbirth. 2025 May 28;25(1):619. doi: 10.1186/s12884-025-07731-9.

Reference Type DERIVED
PMID: 40437451 (View on PubMed)

Symon A, Lightly K, Howard R, Mundle S, Faragher B, Hanley M, Durocher J, Winikoff B, Weeks A. Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool. BMC Med Res Methodol. 2023 Sep 28;23(1):214. doi: 10.1186/s12874-023-02016-1.

Reference Type DERIVED
PMID: 37759174 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34325670 (View on PubMed)

Other Identifiers

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4007

Identifier Type: -

Identifier Source: org_study_id