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.: PACTR202206797734088 Date of Registration: 10/06/2022
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title A Randomized Controlled Trial on Expectant versus Active Management with Sublingual Prostaglandin E-1 Analogue for Term Premature Rupture of the Fetal Membranes
Official scientific title A Randomized Controlled Trial on Expectant versus Active Management with Sublingual Prostaglandin E-1 Analogue for Term Premature Rupture of the Fetal Membranes
Brief summary describing the background and objectives of the trial Premature Rupture of the Fetal Membranes (PROM) is defined as the rupture of integrity of the fetal membranes before the onset of labour, and resulting in leakage of amniotic fluid. As the interval between rupture of the fetal membranes at term and delivery increases, so may the risk of fetal and maternal infection and other complications. It is not resolved whether immediate or delayed induction of labour after term PROM will reduce these risks or whether labour induction could cause more complications than not inducing labour. There is need to carry out a prospective, randomized controlled study to evaluate the results of the two modes of management. The objective of the study is to determine the effects of expectant and active management of Term PROM on the stated fetomaternal outcomes in pregnant women with term PROM.
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 Term Premature Rupture of Fetal Membranes
Purpose of the trial Treatment: Other
Anticipated trial start date 03/06/2022
Actual trial start date 13/06/2022
Anticipated date of last follow up 03/09/2022
Actual Last follow-up date 13/09/2022
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants)
Recruitment status Completed
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 Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Expectant management Management of term Premature Rupture of Fetal Membranes group From rupture of fetal Membranes to Delivery Participants in group-A (expectant management group) were kept for observation with sterile vulval pad for 24 hours from the time of PROM to await spontaneous onset of labour pains, In this group, most of the women were expected to go into spontaneous labour in 24 hours. For participants that did not go into spontaneous labour, Induction of labour was commenced after 24 hours with sublingual misoprostol as in the active management group 43 Uncontrolled
Experimental Group Active management of Term Premature Rupture of Fetal Membranes From rupture of fetal Membranes to delivery The Participants in group-B (active management group) were induced using sublingual PGE1 analogue tablet (misoprostol) 25µg and repeated after 4 hours if they had not gone into labour. The women who did not respond to induction using misoprostol within a 24-hour period with a cumulative dose of 150μg were given treatment with an intravenous infusion of oxytocin at the doses usually administered for the induction of labour 43
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
i. Gestational age 37weeks plus zero day to 41 weeks plus 2 days ii. Singleton pregnancy iii. Age 2034 years iv. Adequate pelvis v. Vertex presentation vi. Cervical dilatation less than 4cm vii. Live baby with normal cardiotocography (CTG) readings and ultrasound finding I. Age <20 years , >34 years II. Gestational age<37 weeks plus zero day, >41weeks plus 2 days III. Multiple pregnancy IV. Chorioamnionitis V. Medical disorders in pregnancy VI. Obstetric complications VII. Grand multipara VIII. Previous caesarean delivery IX. Meconium stained liquour X. Cephalopelvic disproportion XI. Malpresentation XII. Intrauterine fetal death XIII. Prolonged PROM XIV. Cervical dilatation up to 4cm XV. In vitro fertilization pregnancies XVI. Multiple vaginal examinations prior to presentation XVII. Cervical incompetence 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 02/06/2022 ESUTH University Teaching Hospital Park lane Ethics committee
Ethics Committee Address
Street address City Postal code Country
Park Avenue GRA Enugu, Nigeria Enugu 400102 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary outcome measure was the final route of delivery. Delivery
Secondary Outcome The secondary outcomes were the PROM to Delivery Interval, Latency Period and Recruitment to Delivery Interval Delivery Complications like Post Partum haemorrhage, Contractility Patterns, Fetal and Perinatal Outcomes as exemplified by APGAR Scores asphyxia as a measure of presumed perinatal , NICU Admissions and Care, and the Length of the NICU Admission. Delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Enugu State University Teaching Hospital Park lain Enugu Park Ln Hospital Rd, GRA Enugu Enugu 400102 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Fredrick Awkadigwe Park lane Avenue GRA Enugu Nigeria Enugu 400101 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor The Principal investigator Dr Awkadigwe Fredrick Ikenna Department of Obstetrics and Gynaecology, ESUTH Park lane Enugu Enugu 400102 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Joseph I Ikechebelu Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi 435101 Nigeria
Dr Chukwuemeka C. Okoro Nnewi Onitsha road Nnewi Anambra State Nigeria Nnewi 435101 Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Scientific Enquiries Chigozie Okafor chigolz@yahoo.com +2348034802657 Nnewi Onitsha road Nnewi.
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Department of Obstetrics and Gynaecology NAUTH
Role Name Email Phone Street address
Public Enquiries George Eleje georgel21@yahoo.com +2348068117444 Nnewi Onitsha road, Nnewi, Anambra state
City Postal code Country Position/Affiliation
Nnewi 435101 Nigeria Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi
Role Name Email Phone Street address
Principal Investigator Fredrick Awkadigwe awkadigweikenna@gmail.com +2340039555380 Park lane Avenue GRA Enugu
City Postal code Country Position/Affiliation
Enugu 400101 Nigeria Department of Obstetrics and Gynaecology ESUTH Park lane Enugu
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 Clinical Study Report,Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end time frame Not applicable
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