Failure of Vaginal Delivery After Induction

NCT02758340 | Completed Phase 3 DMC

• 1 other identifier: KarachiDMC
• Study Type: interventional
• Target: 335
• Locations: 1 country
• Sites: 1

Brief Summary

The study will compare the number of women who deliver vaginally after artificial initiation of labor pains(i.e. induction of labor) by two methods. Half of the women would receive tablet misoprostol vaginally and the other half would receive tablet misoprostol and foley's balloon catheter both.

Conditions

Labor Pain

Keywords

induction of labor; misoprostol; foley's balloon catheter

Outcome Measures

Primary Outcomes (1)

• failure of vaginal delivery i.e.percentage of women in both groups who would fail to deliver vaginally after 24 hours of induction.

  six months

Study Arms (2)

M=misoprostol

EXPERIMENTAL

Patients who would receive Only oral misoprostol{(50 micrograms) tab cytotec ¼ tablets (Searle)}. All patients in this group will be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes). If labor is not established within 4 hours of the administration of the fourth dose, induction will be considered to be failed

Drug: Misoprostol

M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER

EXPERIMENTAL

All patients in this group will be explained the technique of foley's catheter ballooning and informed consent will be taken. The cervix will be visualized with the help of Cusco's speculum. The balloon will be inflated with about 30 cc of sterile water. The catheter will be pulled down to bring the balloon into the cervical canal and will be tapped around the thigh. Patients will also be given oral misoprostol 50 μg per dose. The dose will be repeated at 4 hours interval up to a maximum of 4 doses till labor is induced (3 contractions per 10 minutes).

Drug: Misoprostol; Device: foley's balloon catheter

Interventions

Misoprostol DRUG

Women would be given misoprostol tablet by mouth

Also known as: cytotec

M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER; M=misoprostol

foley's balloon catheter DEVICE

foley's balloon catheter would be inserted through vagina into cervix.

Also known as: foley's catheter

M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Gestational age \> 37 weeks assessed by Last Menstrual Period and dating scan.
• Women with singleton pregnancy assessed by ultrasound.
• Fetus in vertex presentation assessed by ultrasound.
• Age 20-40 years.
• Bishop score \<4.

You may not qualify if:

• Non-consenting.
• Gestational age \< 37 weeks.
• Patients with history of placenta previa.
• Patients with history of placental abruption.
• Ruptured membranes.
• Patients with history of vaginal infection.
• Patients with history of congenital anomalies in previous deliveries.
• Patients with history of stroke, renal impairment and chronic obstructive pulmonary disease, chronic liver disease and congestive cardiac failure

Sponsors & Collaborators

• Karachi Medical and Dental College: lead

Study Sites (1)

Abbasi shaheed hospital

Karachi, Sindh, 74700, Pakistan

Location

Related Publications (1)

• de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

  PMID: 36996264 DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• samia husain, MBBS

  Karachi Medical and Dental College

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: postgraduate trainee

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 29, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)