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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202506646284255 Date of Registration: 19/06/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Official scientific title Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Brief summary describing the background and objectives of the trial Oxytocin is the first line drug for prevention of PPH . It is often difficult to maintain the potency of the drug in a stable cold chain system in our locality due to incessant power outages. Misoprostol, a heat stable uterotonic agent given alongside oxytocin may improve its efficacy and reduce vaginal bleeding following vaginal delivery. This study seeks to determine and compare the mean postpartum blood loss following vaginal delivery for individuals who receive oxytocin alone and oxytocin with adjunctive misoprostol
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 Prevention
Anticipated trial start date 01/07/2025
Actual trial start date
Anticipated date of last follow up 01/06/2026
Actual Last follow-up date
Anticipated target sample size (number of participants) 198
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 Permuted block randomization Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Misoprostol and oxytocin 600 mcg 10iu goxytocin Within one monute of birth Within one minute of vaginal delivery the intervention arm will receive 10 i u oxytocin, in addition to 600 mcg of misoprostol sublingually 99
Control Group Oxytocin 10 i.u 10 i.u Within one minute of birth 10 i.u of oxytocin will be given intramuscularly with one minute of birth of the baby 99 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
These will include all parturients who are 18 years or older Gestational ages from 37 to 41 weeks In active labour and having successful vaginal deliveries Consent to be part of the study. These will include parturients who do not give their consent, preterm delivery, caesarean section, patients with anaemia (Hb < 10g/dl), coagulation disorders, antepartum haemorrhage, previous history of uterine rupture, conditions requiring prophylactic oxytocin infusion after delivery (e.g. multiple pregnancy, previous history of PPH, etc) Any contraindications to prostaglandin use. Patients who presented in third stage of labour Patient with perineal lacerations and cervical laceration Adolescent: 13 Year(s)-17 Year(s),Adult: 18 Year(s)-44 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 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 16/01/2025 NAUTH HREC
Ethics Committee Address
Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Oraifite road Nnewi 435101 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean postpartum blood loss between the groups Immediately after delivery of placenta, then hourly until 24 hours following delivery
Secondary Outcome II. Secondary outcome measures will include; the need for additional uterotonics, blood transfusion, and adverse effects of medication (nausea, vomiting, shivering, hypotension etc). Within 24 hours of vaginal birth
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Nnamdi Azikiwe University Teaching Hospital Nnewi Oraifite road Nnewi Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ezenwafor Ogonna Obstetrics and gynaecology department NAUTH Nnewi Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Ogonna Ezenwafor OBGYN department NAUTH Nnewi Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Ikeotuonye Arinze OBGYN department NAUTH Nnewi Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ogonna Ezenwafor onyekogoeze@gmail.com +2348063735575 OBGYN department NAUTH
City Postal code Country Position/Affiliation
Nnewi Nigeria Senior Resident doctor
Role Name Email Phone Street address
Public Enquiries Ezeama Chukwuemeka co.ezeama@unizik.edu.ng +2348037167284 OBGYN department NAUTH
City Postal code Country Position/Affiliation
Nnewi Nigeria Professor of OBGYN
Role Name Email Phone Street address
Scientific Enquiries Arinze Ikeotuonye arinze790@gmail.com +2348038730293 OBGYN department NAUTH
City Postal code Country Position/Affiliation
Nnewi Nigeria Consultant OBGYN
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual data during the study period and after the de-identification process will be shared Study Protocol Within 1 year of completion of the study Requests for data will be open No restrictions Decisions on data sharing will be made by the Principal investigator
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 Public title 08/06/2025 Initial one in capital letters and not appropriate SUBLINGUAL MISOPROSTOL AND OXYTOCIN VERSUS OXYTOCIN ALONE FOR PREVENTING PRIMARY POSTPARTUM HAEMORRHAGE AFTER VAGINAL DELIVERY IN NAUTH NNEWI, NIGERIA: A DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED STUDY Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Public title 19/06/2025 PACTR Admin Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 08/06/2025 Initial one in capital letters and not appropriate SUBLINGUAL MISOPROSTOL AND OXYTOCIN VERSUS OXYTOCIN ALONE FOR PREVENTING PRIMARY POSTPARTUM HAEMORRHAGE AFTER VAGINAL DELIVERY IN NAUTH NNEWI, NIGERIA: A DOUBLE-BLIND RANDOMISED PLACEBO-CONTROLLED STUDY Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Official scientific title 19/06/2025 PACTR Admin Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study Sublingual misoprostol and oxytocin versus oxytocin alone for preventing primary postpartum hemorrhage after vaginal delivery in Nnamdi Azikiwe University Teaching Hospital Nnewi, Nigeria: A double-blind randomised placebo controlled study
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Trial description 11/06/2025 Grammatical and typographical errors corrected Oxytocin is the firstline drug for prevdntion . It. Misoprostol a heat stable uterotonic agent given alongside oxytocin may improve its efficacy and reducin vaginal bleeding following vaginal bleeding ' adTgis study seeks to determine and compare the mean postpartum blood loss following vaginal delivery for individual who receive oxytocin alone and adjunctive misoprostol and oxytocinministration delays and poor stability from inadequate cold chain storsges effective can be hindered by inadequate dosing,and management of PPH. Oxytocin is the first line drug for prevention of PPH . It is often difficult to maintain the potency of the drug in a stable cold chain system in our locality due to incessant power outages. Misoprostol, a heat stable uterotonic agent given alongside oxytocin may improve its efficacy and reduce vaginal bleeding following vaginal delivery. This study seeks to determine and compare the mean postpartum blood loss following vaginal delivery for individuals who receive oxytocin alone and oxytocin with adjunctive misoprostol
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 08/06/2025 All age groups not picked initially Adult: 19 Year-44 Year Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s)