Efficacy and Safety of Oral Misoprostol 25 μg vs. Vaginal Dinoprostone in Induction of Labor at Term

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04955847

Acronym

MISODINO

Enrollment

706

Registered

2021-07-09

Start date

2021-01-15

Completion date

2021-05-08

Last updated

2026-06-12

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

Conditions

Cesarean Section, Induction of Labor, Vaginal Delivery

Keywords

Induction of Labor, PGE1, PGE2, vaginal delivery, cesarean section

Brief summary

Labor induction is a common medical technique. There is no consensus on which technique is better than the others. Misoprostol is an analogue of Prostaglandin E1 previously used off-label in labor induction. Its low cost, room-temperature storage, and diverse route options have made it an alternative to PGE2 in labor induction. As of 2018, oral misoprostol 25 μg tablet was licensed for labor induction. Very few studies have been performed on oral misoprostol 25 μg and none compared it with the PGE2s mostly used in induction on unfavorable cervix at term. The investigators compared the safety and the efficacy between the oral misoprostol 25 μg Angusta® used since 20/02/2020 and the vaginal dinoprostone previously used in gel or diffuser over two consecutive periods from 01/01/2019 to 19/02/2020 for the dinoprostone and from 20/02/2020 to 07/04/2021 for the misoprostol.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* age of patient\> 18 years * patients requiring induction of labor with a singleton pregnancy at term, a gestational age greater than 37 weeks of amenorrhea, with a fetus in cephalic presentation and an unfavorable cervix (Bishop score less than six).

Exclusion criteria

* intrauterine fetal death, * preterm pregnancy, * scarred uterus * contraindications to vaginal delivery.

Design outcomes

Primary

Measure	Time frame
Variation of vaginal deliveries within 24hours patient number in both groups	24 hours

Secondary

Measure	Time frame
Variation of Cesarean section patient number in both groups	24 hours
Variation of indications for cesarean section in both groups	24 hours
Variation of uterine contractility abnormalities in both groups	24 hours

Countries

France

Outcome results