A randomised trial to evaluate misoprostol for induction of labour following prelabour rupture of the amniotic membranes

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN57007037

Enrollment

1890

Registered

2005-09-09

Start date

2002-02-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of labour Pregnancy and Childbirth

Interventions

Randomisation to dinoprostone or misoprostol

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Decision to induce labour in the presence of PROM 2. >34 weeks gestation 3. Singleton, live fetus 4. Normal admission cardiotocograph (CTG)

Exclusion criteria

Exclusion criteria: 1. Multiple pregnancy 2. Breech presentation 3. Previous Caesarean section

Design outcomes

Primary

Measure	Time frame
1. Caesarean section (measure of safety) 2. Vaginal delivery within 24 hours of trial entry (measure of clinical effectiveness)	—

Secondary

Measure	Time frame
1. Labour 2. Delivery 3. Pueperium 4. Neonatal Morbidity 5. Satisfaction - Women's satisfaction, Caregiver's satisfaction 6. Womens' and midwives' views and experiences of participating in the PROMMIS Trial	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026