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.: PACTR202306493754084 Date of Approval: 19/06/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Maternal and perinatal outcomes following induction of labour at 40 weeks and 41 weeks at the University of Ilorin Teaching Hospital.
Official scientific title Maternal and perinatal outcomes following induction of labour at 40 weeks and 41 weeks at the University of Ilorin teaching Hospital.
Brief summary describing the background and objectives of the trial Background : Pregnancy lasting 294 days and beyond often invokes maternal concern about delay past the expected date of delivery. A vital component of a healthy pregnancy is the timing of delivery with an existing increase in morbidity and mortality on both ends of the gestational age at delivery spectrum. There is an associated increased risk of adverse maternal and perinatal outcomes with post-term pregnancy which is defined as a pregnancy at or beyond 42 weeks + 0 days by the WHO. However, adverse perinatal outcomes have been shown to start increasing after 40weeks of gestation. Induction of labour is defined as the artificial initiation of uterine contractions after the age of viability before its spontaneous onset for the purpose of achieving vaginal delivery. The preferred timing for induction of labour still remains indistinct. General Aims and Objectives: To compare the maternal and perinatal outcomes following induction of labour at 40weeks (40weeks+0day to 40weeks+6days) to induction of labour at 41weeks (41weeks+0day to 41weeks+6days) in the University of Ilorin Teaching Hospital.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Obstetrics and Gynecology
Sub-Disease(s) or condition(s) being studied maternal and perinatal outcomes following induction of labour at 40weeks versus 41weeks gestation
Purpose of the trial induction of labour
Anticipated trial start date 01/09/2023
Actual trial start date
Anticipated date of last follow up 01/03/2024
Actual Last follow-up date
Anticipated target sample size (number of participants) 106
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
ERC PIN2023021166 University of Ilorin Teaching Hospital ethical committee
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
Crossover: all participants receive all interventions in different sequence during study Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group induction of labour 25microgram of misoprostol 4hourly 24hours the patient will present to the antenatal clinic in the 40th week ( 40weeks + 0-6days) of pregnancy, these patients will be admitted into the antenatal ward from the clinic where they will be examined, a written informed consent will be taken. A general examination will be done checking for palor, jaundice, dehydration and pedal edema, the pulse rate and blood pressure will be checked. An abdominal examination will be done to check for compatibility of the symphysiofundal height with the gestational age, uterine contractions, lie and presentation of the baby, decent of the baby, and the fetal heart rate will be heard with the use of pinnard. The patient will then be placed in dorsal position and a sterile vaginal examination will be done to assess for the Bishop’s score. The position, consistency, dilatation and effacement of the cervix as well as the station of the presenting part will be assessed to calculate the Bishop’s score. An ultrasound scan will be requested for fetal biophysical profile, pack cell volume will be done and at least a pint of blood will be grouped and cross- matched. For patients with Bishop’s score of ≤ 6 and optimal biophysical profile, cervical ripening and induction of labour will be commenced with 25microgram of misoprostol passed into the posterior vaginal fornix 4hourly until a Bisop’s Score of 7 or a maximum of 6 doses is passed as recommended by the ACOG guidelines on the recommendation for misoprostol use. 53
Control Group induction of labour 25microgram misoprostol 4hourly 24hours the patients will be asked to present in the 41st week ( 41weeks + 0-6days) of pregnancy, these patients will be admitted into the antenatal ward from the clinic where they will be examined, a written informed consent will be taken. A general examination will be done checking for palor, jaundice, dehydration and pedal edema, the pulse rate and blood pressure will be checked. An abdominal examination will be done to check for compatibility of the symphysiofundal height with the gestational age, uterine contractions, lie and presentation of the baby, decent of the baby, and the fetal heart rate will be heard with the use of pinnard. The patient will then be placed in dorsal position and a sterile vaginal examination will be done to assess for the Bishop’s score. The position, consistency, dilatation and effacement of the cervix as well as the station of the presenting part will be assessed to calculate the Bishop’s score. An ultrasound scan will be requested for fetal biophysical profile, pack cell volume will be done and at least a pint of blood will be grouped and cross- matched. For patients with Bishop’s score of ≤ 6 and optimal biophysical profile, cervical ripening and induction of labour will be commenced with 25microgram of misoprostol passed into the posterior vaginal fornix 4hourly until a Bisop’s Score of 7 or a maximum of 6 doses is passed as recommended by the ACOG guidelines on the recommendation for misoprostol use. 53 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Consenting pregnant women ≥ 18years to 45years of age Singleton pregnancy with cephalic presenting fetus Pregnancy at 40weeks + 0day to 40weeks + 6days gestation (group A) and 41weeks + 0day to 41weeks + 6days gestation (group B). Previous caesarean section or other uterine surgeries Contraindications to vaginal delivery ( placenta previa, contracted pelvis) Oligohydramnios ( AFI ≤ 5.0cm or single deepest vertical pocket ≤ 2cm ) Diagnosed congenital fetal anomaly. Grand multiparous women Unbooked women Adult: 19 Year-44 Year 18 Year(s) 45 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 26/04/2023 University of Ilorin Teaching hospital ethical review committee
Ethics Committee Address
Street address City Postal code Country
Oke-Oyi Ilorin 1459 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measures will be induction of labour to delivery interval, mode of delivery, and incidence of failed induction of labour. At the delivery of the baby. incidence of failed induction will be measured if vaginal delivery was not achieved or the cervix was still not favourable after 6doses of misoprostol had been passed.
Secondary Outcome The secondary outcome measures will be need for NICU admission and maternal satisfaction. need for NICU admission will be determined at delivery of the baby. maternal satisfaction will be measured after delivery of the baby
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Ilorin Teaching Hospital Oke-Oyi Ilorin Kwara state 240003 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self Irewolede Ilorin Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Areo Olubusayo Irewolede Ilorin Nigeria self
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Olubusayo Areo areobusayo@gmail.com +2348034276724 honourable quarters, Irewolede, ilorin
City Postal code Country Position/Affiliation
Ilorin Nigeria Senior registrar
Role Name Email Phone Street address
Public Enquiries kikelomo Adesina teminikike@yahoo.com +2348033813442 Obstetrics and Gynaecology department, UITH
City Postal code Country Position/Affiliation
Ilorin Nigeria Professor of Obstetrics and Gynaecology
Role Name Email Phone Street address
Scientific Enquiries Kehinde Ibiyemi kfibiyemi@yahoo.co.uk +2348034205043 Obstetrics and Gynaecology Department, UITH
City Postal code Country Position/Affiliation
Ilorin Nigeria Consultant Obstetrics and Gynaecology
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes all of the individual participant data collected during the trial, after deidentification, study protocol, and clinical study report will be made available beginning 12months following article publication Study Protocol 12months open access
URL Results Available Results Summary Result Posting Date First Journal Publication Date
http 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