A trial to see which form of the drug Misoprostol used for induction of labour is more effective and safer- in fluid form given at regular intervals starting at low dose or as a tablet with fixed dose.

A Randomised Controlled Trial for the comparison of the efficacy and safety of Titrated Oral Misoprostol Solution versus Oral Misoprostol Tablet for Induction of Labour

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/03/051096

Enrollment

110

Registered

2023-03-27

Start date

Unknown

Completion date

Unknown

Last updated

2023-04-03

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

Conditions

Health Condition 1: O80- Encounter for full-term uncomplicated delivery

Interventions

Intervention1: Titrated oral Misoprostol Solution: Titrated oral Misoprostol Solution given hourly for 6 hours and maximum 7 doses following induction with Mifepristone and Foley EASI Control Interven

Eligibility

Inclusion criteria

Inclusion criteria: 1. primigravida 2. 37-40 weeks of pregnancy 3. singleton pregnancy with cephalic presentation 4. no uterine scar 5. Bishop score less than or equal to 6

Exclusion criteria

Exclusion criteria: 1.women with contraindications or hypersensitivity to misoprostol 2. women who do not consent to partiipate in the study

Design outcomes

Primary

Measure	Time frame
1. To compare the induction delivery interval in both arms 2. To compare the caesarean delivery rate in both armsTimepoint: Time period from the start of induction of labour to the delivery of the patient	—

Secondary

Measure	Time frame
1. To compare the need for Oxytocin augmentation in Titrated Oral Misoprostol Solution and Oral Misoprostol Tablet in both arms 2. To compare the incidence of Tachysystole in both arms 3. To compare the occurrence of meconium stained amniotic fluid in both arms 4. To compare the non-reassuring Fetal Heart Rate(FHR) tracing in both arms 5. To know the number of NICU admissions in both arms 6. To compare the number of patients with adverse drug reaction to Misoprostol in both armsTimepoint: Time period from the start of induction of labour to the delivery of the patient	—

Measure

Time frame

1. To compare the need for Oxytocin augmentation in Titrated Oral Misoprostol Solution and Oral Misoprostol Tablet in both arms 2. To compare the incidence of Tachysystole in both arms 3. To compare the occurrence of meconium stained amniotic fluid in both arms 4. To compare the non-reassuring Fetal Heart Rate(FHR) tracing in both arms 5. To know the number of NICU admissions in both arms 6. To compare the number of patients with adverse drug reaction to Misoprostol in both armsTimepoint: Time period from the start of induction of labour to the delivery of the patient

—

Countries

India

Contacts

Public ContactDr Lara Raveendran

Rajagiri Hospital

ajithasudhamma@gmail.com

Outcome results

None listed

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