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Failure of Vaginal Delivery After Induction

NCT ID: NCT02758340

Last Updated: 2016-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Artificial initiation of labor pains has become a common occurrence. A variety of methods are employed to initiate labor pains. Labor pains are more successful in culminating into vaginal delivery if the neck of womb that is the cervix is soft (ripe). This is usually achieved by ripening agents. They include drugs and devices that help soften the cervix. Misoprostol and foley's balloon catheter both are used to soften the cervix so that vaginal delivery is possible. Both work on different aspects of the softening of cervix.

Misoprostol acts on shortening the cervix and making it more pliable Foley's balloon helps to open up the cervix that is it aids in dilating the cervical canal.

Conditions

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Labor Pain

Keywords

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induction of labor misoprostol foley's balloon catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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M=misoprostol

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

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Women would be given misoprostol tablet by mouth

M+F=MISOPROSTOL+FOLEY'S BALLOON CATHETER

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).

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Women would be given misoprostol tablet by mouth

foley's balloon catheter

Intervention Type DEVICE

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

Interventions

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Misoprostol

Women would be given misoprostol tablet by mouth

Intervention Type DRUG

foley's balloon catheter

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

Intervention Type DEVICE

Other Intervention Names

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cytotec foley's catheter

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Karachi Medical and Dental College

OTHER

Sponsor Role lead

Responsible Party

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samia husain

postgraduate trainee

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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samia husain, MBBS

Role: PRINCIPAL_INVESTIGATOR

Karachi Medical and Dental College

Locations

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Abbasi shaheed hospital

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

References

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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.

Reference Type DERIVED
PMID: 36996264 (View on PubMed)

Other Identifiers

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KarachiDMC

Identifier Type: -

Identifier Source: org_study_id