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

S

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)

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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