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

Induction of Labor Clinical Trial

— MOLI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03749902
• Other study ID #: 4007
• Status: Completed
• Phase: Phase 4
• Start date: January 6, 2020
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: University of Liverpool
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
India	Daga Memorial Women's Hospital	Nagpur	Maharashtra
India	Government Medical College (GMC)	Nagpur
India	Mahatma Gandhi Institute of Medical Sciences	Sevagram	Maharashtra

Sponsors (5)

Lead Sponsor	Collaborator
University of Liverpool	Daga Memorial Women's Hospital, Nagpur, India, Government Medical College, Nagpur, Gynuity Health Projects, Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caesarean birth	Rate of caesarean birth in the treatment arm	At delivery