Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202604807781933 Date of Registration: 21/04/2026
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Study Comparing Oxytocin and Misoprostol for Starting Labour After Foley Catheter Cervical Ripening
Official scientific title Comparative study of oxytocin and misoprostol for induction of labour following cervical ripening with foleys catheter: a randomised control trial
Brief summary describing the background and objectives of the trial BACKGROUND Labour induction is a key obstetric procedure aimed at achieving vaginal delivery before spontaneous labour onset. Successful induction requires adequate cervical ripening. In Nigeria, the Foley catheter, misoprostol, and oxytocin are commonly used due to affordability and availability. However, the optimal sequential method—particularly which pharmacological agent to use after mechanical ripening—remains uncertain. OBJECTIVES 1.To measure and compare the mean time (in hours) from initiation of misoprostol versus oxytocin to vaginal delivery among term women who underwent Foley catheter ripening, within the defined study period. 2.To compare the proportion of Caesarean deliveries between women induced with misoprostol and those induced with oxytocin following Foley catheter ripening, during the study period. 3.To measure and compare the incidence of uterine hyperstimulation in the misoprostol and oxytocin groups following Foley catheter ripening, during the study period. 4.To compare Apgar scores at 1 and 5 minutes and rates of NICU admission between neonates born to women induced with misoprostol versus oxytocin, within the study timeframe. 5.To measure and compare the time from initiation of misoprostol versus oxytocin to the onset of active labour among women after Foley catheter ripening, within the study period. 6.To determine and compare the incidence of postpartum haemorrhage between the misoprostol and oxytocin groups during the defined study period.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied INDUCTION OF LABOUR
Purpose of the trial Treatment: Drugs
Anticipated trial start date 01/06/2026
Actual trial start date
Anticipated date of last follow up 30/09/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 136
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Misoprostol group 25 microgram of misoprostol 4-6hrly x 4 doses Participants randomized to the misoprostol group will receive **Misoprostol for induction of labour following cervical ripening with a Foley catheter. After removal of the Foley catheter and confirmation of adequate cervical ripening, 25 micrograms of vaginal misoprostol will be administered into the posterior vaginal fornix every 4–6 hours until adequate uterine contractions are established or a maximum of four doses is reached. Administration will be discontinued if: Adequate labour is established (defined as regular uterine contractions with progressive cervical dilatation), Uterine tachysystole or fetal distress occurs, or The maximum allowable dose is reached. Maternal vital signs, uterine contractions, and fetal heart rate will be monitored throughout labour according to institutional protocol. 68
Control Group Oxytocin group Participants randomized to the oxytocin group will receive 2.5 IU of oxytocin diluted in 500 mL of normal saline (5 mIU/mL) administered via an infusion pump. The infusion will commence at 2 mIU/min (24 mL/hour) and will be increased by 2 mIU/min every 30 minutes until adequate uterine contractions are achieved. 8 TO 12HRS Participants randomized to the oxytocin group will receive 2.5 IU of oxytocin diluted in 500 mL of normal saline (5 mIU/mL) administered via an infusion pump. The infusion will commence at 2 mIU/min (24 mL/hour) and will be increased by 2 mIU/min every 30 minutes until adequate uterine contractions are achieved. Adequate uterine contractions will be defined as 3–5 contractions in 10 minutes lasting 40–60 seconds. The maximum infusion rate will be 10 mIU/min unless adequate labour is established earlier. The infusion will be reduced or discontinued if any of the following occur: Uterine tachysystole Non-reassuring fetal heart rate pattern Hypertonic uterine contractions Oxytocin Escalation Regimen Dose (mIU/min) mL/min mL/hour (Infusion pump) Drops/min (20 drops = 1 mL) 2 mIU/min 0.4 mL 24 mL/hr 8 drops/min 4 mIU/min 0.8 mL 48 mL/hr 16 drops/min 6 mIU/min 1.2 mL 72 mL/hr 24 drops/min 8 mIU/min 1.6 mL 96 mL/hr 32 drops/min 10 mIU/min 2.0 mL 120 mL/hr 40 drops/min 68 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
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. 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. Adult: 18 Year(s)-44 Year(s) 19 Year(s) 44 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 16/02/2026 HEALTH RESEARCH AND ETHICS COMMITTEE OF LAGOS STATE UNIVERSITY TEACHING HOSPITAL
Ethics Committee Address
Street address City Postal code Country
1-5 Oba Akinjobi Way, Ikeja, Lagos, Nigeria. Ikeja PMB 21005 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Induction to delivery interval and Caesarean section rate. AT DELIVERY AND AT THE COMPLETION OF THE STUDY
Secondary Outcome 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. FROM THE COMMENCEMENT OF INDUCING AGENT
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
LAGOS STATE UNIVERSITY TEACHING HOSPITAL 1-5 Oba Akinjobi Way, Ikeja, Lagos, Nigeria. IKEJA 101233 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Bello Adekunle Stephen 1-5 Oba Akinjobi Way, Ikeja, Lagos, Nigeria. Lagos 101233 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor BELLO ADEKUNLE STEPHEN 1-5 OBA AKINJOBI WAY IKEJA IKEJA 101233 Nigeria SELF
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator ADEKUNLE BELLO dradekunlestephen@gmail.com 07032603830 1-5 OBA AKINJOBIWAY IKEJA
City Postal code Country Position/Affiliation
IKEJA Nigeria SENIOR REGISTRAR
Role Name Email Phone Street address
Public Enquiries OLADIMEJI MAKINDE MAKINDEOLADIMEJI@GMAIL.COM 08055147967 1-5 OBA AKINJOBI WAY IKEJA
City Postal code Country Position/Affiliation
IKEJA Nigeria SUPERVISOR 2
Role Name Email Phone Street address
Scientific Enquiries ADENIYI ADEWUMI abiodun.adewunmi@lasucom.edu.ng 08023077827 1-5 OBA AKINJOBI WAY IKEJA
City Postal code Country Position/Affiliation
IKEJA Nigeria SUPERVISOR
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data collected during this study will not be publicly available due to confidentiality and ethical considerations. However, de-identified data may be made available upon reasonable request to the principal investigator, subject to approval by the institutional ethics committee and compliance with institutional data-sharing policies. Clinical Study Report 1YEAR OPEN
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 29/03/2026 As corrected by the reviewer COMPARATIVE STUDY OF OXYTOCIN AND MISOPROSTOL FOR INDUCTION OF LABOUR FOLLOWING CERVICAL RIPENING WITH FOLEYS CATHETER: A RANDOMISED CONTROL TRIAL Comparative study of oxytocin and misoprostol for induction of labour following cervical ripening with foleys catheter: a randomised control trial
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/03/2026 As requested by the reviewer Experimental Group, MISOPROSTOL GROUP, 25 microgram of misoprostol 4-6hrly, x 4 doses, Participants randomized to the misoprostol group will receive **Misoprostol for induction of labour following cervical ripening with a Foley catheter. After removal of the Foley catheter and confirmation of adequate cervical ripening, 25 micrograms of vaginal misoprostol will be administered into the posterior vaginal fornix every 4–6 hours until adequate uterine contractions are established or a maximum of four doses is reached. Administration will be discontinued if: Adequate labour is established (defined as regular uterine contractions with progressive cervical dilatation), Uterine tachysystole or fetal distress occurs, or The maximum allowable dose is reached. Maternal vital signs, uterine contractions, and fetal heart rate will be monitored throughout labour according to institutional protocol., 68,
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/03/2026 As requested by the reviewer Control Group, Oxytocin group, Participants randomized to the oxytocin group will receive 2.5 IU of oxytocin diluted in 500 mL of normal saline (5 mIU/mL) administered via an infusion pump. The infusion will commence at 2 mIU/min (24 mL/hour) and will be increased by 2 mIU/min every 30 minutes until adequate uterine contractions are achieved., 8 TO 12HRS, Participants randomized to the oxytocin group will receive 2.5 IU of oxytocin diluted in 500 mL of normal saline (5 mIU/mL) administered via an infusion pump. The infusion will commence at 2 mIU/min (24 mL/hour) and will be increased by 2 mIU/min every 30 minutes until adequate uterine contractions are achieved. Adequate uterine contractions will be defined as 3–5 contractions in 10 minutes lasting 40–60 seconds. The maximum infusion rate will be 10 mIU/min unless adequate labour is established earlier. The infusion will be reduced or discontinued if any of the following occur: Uterine tachysystole Non-reassuring fetal heart rate pattern Hypertonic uterine contractions Oxytocin Escalation Regimen Dose (mIU/min) mL/min mL/hour (Infusion pump) Drops/min (20 drops = 1 mL) 2 mIU/min 0.4 mL 24 mL/hr 8 drops/min 4 mIU/min 0.8 mL 48 mL/hr 16 drops/min 6 mIU/min 1.2 mL 72 mL/hr 24 drops/min 8 mIU/min 1.6 mL 96 mL/hr 32 drops/min 10 mIU/min 2.0 mL 120 mL/hr 40 drops/min, 68, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 29/03/2026 As requested by the reviewer Experimental Group, MISOPROSTOL GROUP, 25 microgram of misoprostol 4-6hrly, x 4 doses, Participants randomized to the misoprostol group will receive **Misoprostol for induction of labour following cervical ripening with a Foley catheter. After removal of the Foley catheter and confirmation of adequate cervical ripening, 25 micrograms of vaginal misoprostol will be administered into the posterior vaginal fornix every 4–6 hours until adequate uterine contractions are established or a maximum of four doses is reached. Administration will be discontinued if: Adequate labour is established (defined as regular uterine contractions with progressive cervical dilatation), Uterine tachysystole or fetal distress occurs, or The maximum allowable dose is reached. Maternal vital signs, uterine contractions, and fetal heart rate will be monitored throughout labour according to institutional protocol., 68, Experimental Group, Misoprostol group, 25 microgram of misoprostol 4-6hrly, x 4 doses, Participants randomized to the misoprostol group will receive **Misoprostol for induction of labour following cervical ripening with a Foley catheter. After removal of the Foley catheter and confirmation of adequate cervical ripening, 25 micrograms of vaginal misoprostol will be administered into the posterior vaginal fornix every 4–6 hours until adequate uterine contractions are established or a maximum of four doses is reached. Administration will be discontinued if: Adequate labour is established (defined as regular uterine contractions with progressive cervical dilatation), Uterine tachysystole or fetal distress occurs, or The maximum allowable dose is reached. Maternal vital signs, uterine contractions, and fetal heart rate will be monitored throughout labour according to institutional protocol., 68,
Section Name Field Name Date Reason Old Value Updated Value
Funding Source FundingSources List 29/03/2026 As corrected by the reviewer SELF, 1-5 Oba Akinjobi Way, Ikeja, Lagos, Nigeria., Lagos, 101233, Nigeria, Self Funded, Dr Bello Adekunle Stephen, 1-5 Oba Akinjobi Way, Ikeja, Lagos, Nigeria., Lagos, 101233, Nigeria, Self Funded,