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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: Female

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?

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gynuity Health Projects; University of Liverpool
• Collaborators: Daga Memorial Women's Hospital, Nagpur, India; Government Dental College and Hospital, India; Government Medical College, Nagpur; Gynuity Health Projects; Mahatma Gandhi Institute of Medical Sciences, Sevagram, Wardha, India; University of Liverpool
• Treatments: Misoprostol; Oxytocin

Criteria

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)