Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.

Saint Thomas Hospital (HST)

Status: Completed

Conditions: Induction of Labor

Treatments: Procedure: 6 misoprostol; Procedure: 3 misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT03489798

MHST2016-04

Details and patient eligibility

About

To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.

Enrollment: 310 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women between 34 and 42 weeks of gestation.
• Obstetric indication for termination of pregnancy.
• No fetal evidence of fetal distress

Exclusion criteria

• Any contraindication for the use of misoprostol.
• Oligohydramnios.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

6 Misoprostol

Experimental group

Description:

Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.

Treatment:

Procedure: 6 misoprostol

3 misoprostol

Active Comparator group

Description:

Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score \> 6.

Treatment:

Procedure: 3 misoprostol