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

Conditions

Induction of Labor

Keywords

preeclampsia, misoprostol, oxytocin

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.

Kate Lightly, Shuchita Mundle, Jaya Prasad Tripathy, Pradeep Deshmukh, Beverly Winikoff et al. (7 authors)

BMJ Global Health2025-09-01

10.1136/bmjgh-2024-018393

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 A, Howard R, Faragher B, Durocher J, Winikoff B, Symon A, Weeks A, Mundle S, Lightly K.

2025-05-28

10.1186/s12884-025-07731-9

Preferences for induction of labor methods in India: a qualitative study of views and experiences of women, clinicians, and researchers.

Hawker LA, Mundle S, Tripathy JP, Deshmukh P, Winikoff B, Weeks AD, Kingdon C, Lightly K.

2024-08-172 citations

10.1016/j.xagr.2024.100389

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

Andrew Symon, Kate Lightly, Rachel Howard, Shuchita Mundle, Brian Faragher et al. (9 authors)

BMC Medical Research Methodology2023-09-284 citations

10.1186/s12874-023-02016-1

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

Hillary Bracken, Kate Lightly, Shuchita Mundle, Robert S. Kerr, Brian Faragher et al. (11 authors)

BMC Pregnancy and Childbirth2021-07-299 citations

10.1186/s12884-021-04009-8

Interventions

DRUGOral 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.

DRUGOxytocin

* 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

No

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)

Design outcomes

Primary

Measure	Time frame	Description
Caesarean birth	At delivery	Rate of caesarean birth in the treatment arm

Countries

India

Outcome results

None listed