A Study Comparing Oxytocin and Misoprostol for Starting Labour After Foley Catheter Cervical Ripening

Comparative study of oxytocin and misoprostol for induction of labour following cervical ripening with foleys catheter: a randomised control trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

PACTR

Registry ID

PACTR202604807781933

Enrollment

136

Registered

2026-04-21

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-06-22

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

Conditions

INDUCTION OF LABOUR

Interventions

Misoprostol group

Oxytocin group

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1.Gestational age of 37 completed weeks or more. 2.Singleton pregnancy with a cephalic presentation. 3.An unfavourable cervix, defined as a Bishop score of = 5, prior to Foley catheter insertion. 4.Successful cervical ripening achieved with a Foley catheter, evidenced by spontaneous expulsion of the catheter or its removal after a predetermined duration. 5.Willingness to participate in the study and provide informed written consent.

Exclusion criteria

Exclusion criteria: 1.Presence of contraindications to vaginal delivery (e.g., cephalopelvic disproportion (CPD), placenta previa, vasa previa, active genital herpes infection). 2.Known hypersensitivity or contraindication to either misoprostol or oxytocin. 3.Significant medical conditions that contraindicate the use of misoprostol or oxytocin (e.g., uncontrolled epilepsy or asthma, severe cardiac, renal, or hepatic disease, glaucoma), unless explicitly managed and deemed eligible by the treating physician. 4.Clinical diagnosis of chorioamnionitis.

Design outcomes

Primary

Measure	Time frame
Induction to delivery interval and Caesarean section rate.	—

Secondary

Measure	Time frame
1.Time interval from the initiation of the second induction agent (misoprostol or oxytocin) to vaginal delivery. 2.Rate of Caesarean section. 3.Incidence of uterine hyperstimulation (defined as uterine tachysystole with or without associated fetal heart rate changes). 4.Need for oxytocin augmentation in the misoprostol group. 5.Incidence of maternal complications, including postpartum haemorrhage, uterine rupture (though rare), other severe maternal morbidity, and infection. 6.Neonatal outcomes, specifically Apgar scores at 1 and 5 minutes, the need for Neonatal Intensive Care Unit (NICU) admission, presence of meconium-stained liquor, and severe perinatal morbidity or death. 7.Time from the initiation of the second agent to the onset of active labour.	—

Measure

Time frame

1.Time interval from the initiation of the second induction agent (misoprostol or oxytocin) to vaginal delivery. 2.Rate of Caesarean section. 3.Incidence of uterine hyperstimulation (defined as uterine tachysystole with or without associated fetal heart rate changes). 4.Need for oxytocin augmentation in the misoprostol group. 5.Incidence of maternal complications, including postpartum haemorrhage, uterine rupture (though rare), other severe maternal morbidity, and infection. 6.Neonatal outcomes, specifically Apgar scores at 1 and 5 minutes, the need for Neonatal Intensive Care Unit (NICU) admission, presence of meconium-stained liquor, and severe perinatal morbidity or death. 7.Time from the initiation of the second agent to the onset of active labour.

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Countries

Nigeria

Contacts

Public ContactOLADIMEJI MAKINDE

SUPERVISOR 2

MAKINDEOLADIMEJI@GMAIL.COM08055147967

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Jun 29, 2026