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?

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.

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)

The data from this study will be confidential until the database is closed at the end of the study. Following this the study investigators will have exclusive access to the data until the publication of the results in a journal. Once this has happened, the database will be open to other researchers upon request. Open access databases will also be sought so as to maximise the availability of our research data with as few restrictions as possible, in line with MRC and Wellcome Trust policy. The consent form will include a clause for the woman to give permission for her anonymous data to be used for future research studies.

The data will be released upon publication of the trial results. After this, the data will be shared on a public database to maximise the viability of the data.

Initially this will be upon request with later public publication of the data.