Induction of labor with Foley cathether or Misoprostol (INFORM)

Induction of labor in preeclamptic women: a randomised trial comparing the Foley baloon catheter with oral misoprostol - INFORM

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2013/07/003859

Enrollment

602

Registered

2013-07-31

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: null- Women with preeclampsia

Interventions

Intervention1: Foley catheter: Women will undergo induction using a transcervical Foley catheter (silicone, size 18F with 30ml balloon) Control Intervention1: Oral misoprostol 25mcg: women will be ind

Eligibility

Inclusion criteria

Inclusion criteria: Women with an ongoing pregnancy with a live fetus in whom the decision has been made to induce vaginal delivery because of preeclampsia or uncontrolled hypertension. Women will be included irrespective of whether an intrapartum caesarean section on fetal grouns would be considered or not.

Exclusion criteria

Exclusion criteria: Women with prior caesarean sections Those unable to give informed consent Multiple pregnancy History of allergy to misoprostol Ruptured membranes Chorioanaionitis (by clinical diagnosis)

Design outcomes

Primary

Measure	Time frame
Vaginal delivery within 24 hoursTimepoint: Vaginal delivery within 24 hours	—

Secondary

Measure	Time frame
Induction to delviery interval, vaginal deliveries within 12 hours, cervix unchanged at 12 and 24 hours, need for oxytocin augmentationTimepoint: 12 hours, 24 hours	—

Countries

India

Contacts

Public ContactDr Shuchita Mundle

Government Medical College, Nagpur

srmundle@gmail.com9822706087

Outcome results

None listed

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