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.: PACTR202408915086048 Date of Approval: 14/08/2024
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Fetomaternal outcomes early versus full-term elective caesarean section
Official scientific title Maternal and fetal outcomes of early versus full term elective caesarean delivery in Federal Medical Centre (F.M.C), Asaba- A Randomised Control Trial.
Brief summary describing the background and objectives of the trial Background: Elective caesarean delivery, which is often performed for obstetric indications, has become increasingly common worldwide. Despite the consensus reached by some institutions on its timing, which is said to be best performed between 39 completed weeks and 40 completed weeks, many Obstetricians still carry out the procedure at less than 39 weeks i.e. between 37 completed weeks and 38 completed weeks for one reason or the other. Majority of the studies that associated elective Caesarean delivery at early term (37 completed weeks to 38 weeks and 6 days) with neonatal respiratory morbidity were done in places other than sub-Saharan Africa. Studies have shown that there’s earlier onset and completion of lung maturity in black fetuses. Immediate and early maternal outcomes following elective Caesarean delivery may include one or more of the following: postpartum haemorrhage, surgical site infection, anaesthetic complications e.t.c. Fetal outcomes, on the other hand, may include one or more of the following: respiratory complications, NICU admission, hypoglycaemia and other metabolic complications, sepsis e.t.c. Given the above stated issues with the consensus on the optimal timing of elective Caesarean delivery, and the potential impact delaying elective Caesarean section till 39 completed weeks could have on the maternal and fetal health, this study aims to compare the maternal and fetal outcomes of early versus full-term elective Caesarean deliveries within the specific context of the Federal Medical Centre, Asaba. By addressing this gap in the literature, this study seeks to provide valuable insights into the optimal timing of elective Caesarean delivery and its implications for maternal and fetal health in our setting Aim: To find out if there are significant differences in feto-maternal outcomes between elective caesarean deliveries performed at early term and full-term gestation in F.M.C, Asaba.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2024
Actual trial start date
Anticipated date of last follow up 30/06/2025
Actual Last follow-up date
Anticipated target sample size (number of participants) 168
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 Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Full term elective Caesarean delivery Elective caesarean section performed between 39 completed weeks and 39 weeks + 6 days Following the recruitment of participants, having met the inclusion criteria and giving consent, participants are randomised into full-term (39 weeks-39 weeks +6 days) and early term (37 completed weeks to 38 weeks + 6 days) elective Caesarean section. Those who are to be electively delivered at full-term gestation will be delivered between 39 weeks to 39 weeks + 6 days. During and following the delivery, they and there babies are monitored for any adverse outcome(s) 84 Active-Treatment of Control Group
Experimental Group Early term elective Caesarean delivery Early term Caesarean delivery between 37 completed weeks and 38 weeks + 6 days Following recruitment of participants, having met the inclusion criteria and given consent, they are randomised into early term elective ( 37 completed weeks to 38 weeks + 6 days) Caesarean delivery and full term (39 completed weeks G.A to 39 weeks + 6 days). Those for early term elective Caesarean delivery will undergo elective Caesarean section between 37 completed weeks and 38 weeks and 6 days. During and following the delivery, participants and their babies are monitored for any adverse outcome(s). 84
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Women with singleton pregnancy with gestational age determined by ultrasound scan at or before 20 weeks gestation will be eligible for inclusion, when a decision of delivery by elective Caesarean section has been made or will be made. -Pregnant women with obstetric complications such as fetal anomalies, -Intrauterine growth restriction -3 previous caesarean section and above scars -Prior extensive myomectomy scars -Placenta previa -Medical complications such as diabetes mellitus in pregnancy, uncontrolled hypertension in pregnancy and sickle cell disease in pregnancy. Adult: 19 Year-44 Year,New born: 0 Day-1 Month 0 Day(s) 45 Year(s) Both
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 15/02/2024 Ethics and Research Committee of Federal Medical Centre
Ethics Committee Address
Street address City Postal code Country
Nnebisi Road, Isieke Asaba 320242 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Neonatal intensive care unit admission of the neonates irrespective of the indication Following delivery
Secondary Outcome The secondary outcome measures will include the incidence of hypothermia, hypoglycaemia, low 1st minute APGAR score, neonatal respiratory morbidity, hyperbilirubinaemia, and neurological morbidity in the neonates. Maternal outcomes of postpartum haemorrhage, bladder injury, need for blood transfusion and the duration of hospital stay in both arms of the study will also be part of the secondary outcome measures. In addition to the above outcome measures, the proportion of women in both arms of the study who were converted to urgent or emergency Caesarean section will also be determined from the study. Intraoperatively and following delivery in the maternity ward/NICU
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Nnebisi Road, Isieke Asaba 320242 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Chizoba Joseph Nwosu Federal Medical Centre, P.M.B 1033, Nnebisi Road, Isieke Asaba 320242 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nwosu Chizoba Joseph Federal Medical Centre Asaba 320242 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Dr Daniel Onwusulu Nnamdi Azikiwe University Teaching, Hospital Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Chizoba Nwosu dr.cj4og@yahoo.com +2347037007143 Federal Medical Centre, Nnebisi Road, Isieke
City Postal code Country Position/Affiliation
Asaba 320242 Nigeria Senior Registrar Obstetrics and Gynaecology department of FMC Asaba
Role Name Email Phone Street address
Public Enquiries Chizoba Nwosu dr.cj4og@yahoo.com +2347037007143 Federal Medical Centre, Nnebisi Road, Isieke
City Postal code Country Position/Affiliation
Asaba 320242 Nigeria Senior Registrar Obstetrics and Gynaecology department FMC Asaba
Role Name Email Phone Street address
Scientific Enquiries Daniel Onwusulu dn.onwusulu@unizik.edu.ng +2348037145801 Nnamdi Azikiwe University Teaching Hospital
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Consultant Obstetrician and Gynecologist NAUTH Nnewi
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Deidentified raw data collected during the study will be shared. Informed Consent Form,Statistical Analysis Plan,Study Protocol Data will be available immediately after the publication of the study results and remain available for 5 years following publication Researchers with a valid research proposal and who agree to the terms of data use will have access to the data
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