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EFFICACY OF VAGINAL MISOPROSTOL AND CERVICAL FOLEY CATHETER VERSUS VAGINAL MISOPROSTOL ALONE ON TERM PREGNANCY LABOUR INDUCTION IN ENUGU: A RANDOMIZED CONTROLLED TRIAL

EFFICACY OF VAGINAL MISOPROSTOL AND CERVICAL FOLEY CATHETER VERSUS VAGINAL MISOPROSTOL ALONE ON TERM PREGNANCY LABOUR INDUCTION IN ENUGU: A RANDOMIZED CONTROLLED TRIAL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
PACTR
Registry ID
PACTR202202769135894
Enrollment
132
Registered
2022-02-01
Start date
2022-03-01
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Fetomaternal

Interventions

vaginal misoprostol and cervical Foley catheter insertion
vaginal misoprostol insertion alone

Sponsors

Dr. Ezenwaeze Malachy Nwaeze
Lead Sponsor
Dr. Leonard Ogbonna Ajah
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Every pregnant woman billed for labour induction at term (37 completed weeks to 41weeks + 6days gestation) with an unfavourable cervix (Bishop score of< 6) who gave consent, with live singleton fetus in longitudinal lie, cephalic presentation and reactive non-stress test will be selected.

Exclusion criteria

Exclusion criteria: Pregnant women at term who fail to give consent, with contraindication to vaginal delivery, multiple gestation, intrauterine fetal death, anomalous fetus, nonreactive stress test, prior uterine rupture/surgery, regular uterine contraction, vaginal bleeding, and premature rupture of membranes will be excluded.

Design outcomes

Primary

MeasureTime frame
The mean time interval it will take to achieve vaginal delivery from the time of induction

Secondary

MeasureTime frame
Proportion of women that will achieve vaginal delivery,need for oxytocin administration. Others will include feto- maternal outcomes by checking and comparing the mean Apgar scores at 1 and 5 minutes, birth asphyxia (using the Apgar scores), use of oxygen on babies, admission into neonatal intensive care unit(NICU) and occurrence of complications such as uterine tachysystole /hyperstimulation (more than five uterine contractions in ten minutes for two consecutive ten minutes periods), uterine hypertonus (uterine contractions lasting more than 90seconds), hyperstimulation syndrome (tachysystole or hypertonus associated with fetal distress), uterine rupture and fetal heart rate abnormalities, failed induction resulting in caesarean delivery.

Countries

Nigeria

Contacts

Public ContactMonique Ajah

Assistant Research Fellow

monique.ajah@unn.edu.ng+2348037331696

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026