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.: PACTR202404517245279 Date of Approval: 04/04/2024
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Maternal And Fetal Outcome Of Planned Induction Of Labour Versus Caesarean Section For Severe Preeclampsia With Unfavourable Cervix At/Or Near Term.
Official scientific title Maternal And Fetal Outcome Of Planned Induction Of Labour Versus Caesarean Section For Severe Preeclampsia With Unfavourable Cervix At/Or Near Term
Brief summary describing the background and objectives of the trial Severe Preeclampsia is associated with increased maternal and perinatal morbidity and mortality. Delivery is the only definitive cure for preeclampsia. The place of cervical ripening and induction of labour in patients with severe preeclampsia and unfavourable cervix is yet to be established. The aim of this study is to compare the maternal and foetal outcomes in women with severe preeclampsia with unfavourable cervix at or near term undergoing caesarean section and cervical ripening/ induction of labour.
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 The other condition include Hypertensive disorder in pregnancy
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/08/2021
Actual trial start date 31/01/2022
Anticipated date of last follow up 31/01/2022
Actual Last follow-up date 31/01/2022
Anticipated target sample size (number of participants) 120
Actual target sample size (number of participants) 120
Recruitment status Active, not recruiting
Publication URL Tropical journal of Obstetrics and Gynaecology
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 planned elective caesarean section no dose 7 days For the caesarean section arm, written informed consent was obtained. Laboratory investigations were done. These included full blood count, blood grouping and cross-matching for 2units of blood, electrolyte, urea, and creatinine, HIV screening (for the unbooked patients) and urinalysis.Following anaesthetist team review, consult was written to the paediatricians. Intravenous line was set up and urethral Foley catheter was passed. Pre -medications with 50mg ranitidine intravenously and perioperative antibiotic (Augmentin 1.2gm) were given.The patient was placed in supine position on the operation table with 15degree left lateral tilt to prevent supine hypotension syndrome.The lower segment caesarean section was done. The Patients were followed up till discharge monitoring the first and fifth minute APGAR, neonatal respiratory distress, neonatal sepsis, Postpartum Heamorrhage, Eclampsia, Renal failure, pulmonary oedema 60 Active-Treatment of Control Group
Experimental Group Planned Induction of labour No dose 7 days Induction of labour was commenced at 6am with 25 microgram misoprostol (Marie Stopes international Nigeria). This was passed into the posterior vaginal fornix. She was reviewed 6 hourly until labour commenced. At each review, her vital signs were checked, abdomen examined for foetal lie, presentation, descent, position. Uterine contractions were palpated for its frequency, strength, and duration if labour had commenced. Auscultation was done to detect foetal heart sound and rate. Six-hourly digital examination was done to assess the cervical effacement dilatation, consistency and position, and station of foetal head. The need for next dose of misoprostol was determined. When she progressed to active phase of labour, labour was monitored with partograph and cardiotocograph. Artificial rupture of membrane was done after excluding cord presentation. The amniotic fluid was examined for colour, odour, blood, and meconium. Augmentation of labour was commenced 1hour after ARM if uterine contraction was not adequate. This was done with 10 IU of oxytocin in 1litre of dextrose saline at 15 drops per minute and escalated every 30 minutes to achieve 3-4 strong uterine contractions in 10minutes. However, 5 IU of oxytocin was used for multigravida to augment labour when necessar.y. The Patients were followed up till discharge monitoring the first and fifth minute APGAR, neonatal respiratory distress, neonatal sepsis, Postpartum Heamorrhage, Eclampsia, Renal failure, pulmonary oedema 60
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
My inclusion criteria included only consenting women with live singleton intrauterine pregnancy from 36 completed weeks to 42 completed weeks, diagnosed with severe preeclampsia in whom unfavourable cervix was the only indication for caesarean delivery. Patients with the following conditions were excluded from participating in the study: 1. Multiple gestations. 2. Spontaneous labour. 3. Foetal distress. 4. Eclampsia 5. Foetal anomaly. 6. Intrauterine growth restriction (IUGR). 7. Severe oligohydramnios 8. Pregnancies with other medical co-morbidities like Diabetes Mellitus, Thyroid disease, and Sickle Cell Disease. 9 Severe preeclampsia with gestational age less than 36 weeks 10. Women with favourable cervical score Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year 18 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 22/02/2021 Health Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Sokoto Bye Pass Road, Gusau, Zamfara State Gusau 860242 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The outcome is to compare the neonatal and maternal outcomes among pregnant women presenting with severe preeclampsia with unfavourable cervix at or near term undergoing caesarean section with those for induction of labour. first and fifth minute of delivery
Secondary Outcome 1. To compare the secondary outcomes – maternal and neonatal outcomes - (occurrence of fits, pulmonary oedema, acute respiratory distress, primary postpartum haemorrhage, haemolysis elevated liver enzymes, and low platelet (HELLP) syndrome, mother’s duration of admission, maternal death, neonatal respiratory distress syndrome, neonatal seizure, duration of SCBU admission, and neonatal sepsis) between patients with severe preeclampsia and unfavourable cervix delivered by caesarean with those that undergo induction of labour and vaginal delivery. 2. To determine the prevalence of severe preeclampsia in Federal Medical Centre Gusau 7 days
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Gusau Sokoto Bye Pass Road Gusau PMB01008 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
self Barakallahu area, Gusau Gusau 860242 Nigeria
self Barakallahu area, Gusau Guasau 860242 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Buraimoh Jimoh Barakallahu Gusau 860242 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Buraimoh Jimoh arewaji@gmail.com 08065745495 Barakallahu area, Gusau
City Postal code Country Position/Affiliation
Gusau 860242 Nigeria Consultant Obstetrician and Gynaecologist
Role Name Email Phone Street address
Public Enquiries Mohammed Abdul maabdul90@gmail.com 08035889959 Ahmad Bello University Teaching Hospital, Zaria
City Postal code Country Position/Affiliation
Zaria 810006 Nigeria Professor of Obstetrics and Gynaecologist
Role Name Email Phone Street address
Scientific Enquiries Abubakar Danladi Danabu99@gmail.com 08030673260 Federal Medical Centre, Gusau
City Postal code Country Position/Affiliation
Gusua 860242 Nigeria Chief consultant Obstetrician and Gynaeologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data collected during the trial will be made available, after deidentification Clinical Study Report,Informed Consent Form,Study Protocol 3 months to 6 months 2 parallel independent analyses
URL Results Available Results Summary Result Posting Date First Journal Publication Date
TJOG 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