Failure of Vaginal Delivery After Induction

Comparison of Maternal Outcome Between Patients Undergoing Induction of Labor With Oral Misoprostol Alone and Oral Misoprostol and Foley's Catheter Both at a Tertiary Care Hospital

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02758340

Enrollment

335

Registered

2016-05-02

Start date

2016-04-30

Completion date

2016-11-30

Last updated

2016-11-29

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

Conditions

Labor Pain

Keywords

induction of labor, misoprostol, foley's balloon catheter

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.

Detailed description

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.

Interventions

DRUGMisoprostol

Women would be given misoprostol tablet by mouth

DEVICEfoley's balloon catheter

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026