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.: PACTR202303865241285 Date of Approval: 23/03/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Artificial versus spontaneous amniotomy in management of spontaneous labour at the university of ilorin teaching hospital: a randomized control trial.
Official scientific title Artificial versus spontaneous amniotomy in management of spontaneous labour at the university of ilorin teaching hospital: a randomized control trial
Brief summary describing the background and objectives of the trial Background: Prolonged labour is associated with adverse maternal, fetal and perinatal outcomes, hence many methods are practiced to shorten the duration of labour, one of them being artificial rupture of membrane. Routine artificial rupture of membranes is a common obstetrics practice but its effectiveness has not been proven. General Aims and Objectives: To determine the effects of artificial amniotomy on the duration of labour, rate of cervical Os dilatation, need for augmentation and other maternal / neonatal out- comes of uncomplicated pregnancies in Ilorin, North-central Nigeria.
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 Artificial versus Spontaneous rupture of fetal membranes in management of spontaneous labour
Purpose of the trial Treatment: Other
Anticipated trial start date 01/10/2022
Actual trial start date
Anticipated date of last follow up 29/03/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 222
Actual target sample size (number of participants)
Recruitment status 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
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
Control Group Artificial rupture of membranes Artificial rupture of membranes will be done for patients that present to the labour ward in active phase of labour with a cervical dilatation of 4-5cm after signing informed consent and randomization Six months The patient will be placed in the dorsal position with her legs flexed at the hip and knee joints and prepared as for vaginal examination, maintaining asepsis (after the washing of hands, sterile gloves will be worn and the vulva will be cleaned using the three swab technique. Cervical dilatation will be confirmed and umbilical cord presentation will be excluded. Two fingers (index and middle fingers) of the dominant hand will be inserted into the cervix and stretched, the membranes will be swept free from the lower segment. A Kocher’s forceps will then be introduced into the vagina with the non-dominant hand and guided up onto the fore-waters passing in between the two fingers of the dominant hand that have already been introduced into the cervix; the fetal membranes will then be ruptured at peak of contraction avoiding injury to maternal or fetal tissues and the amniotic fluid will be let down slowly with the index and middle fingers of the dominant hand still stretched within the cervix in order to prevent cord prolapse. The colour of the amniotic fluid will be noted. After the procedure, cord prolapse will be excluded, the fetal heart rate will be checked again for any abnormality and the patient will be assigned a delivery couch and encouraged to lie on her left side to prevent possible supine hypotension syndrome, and further management of the patient in labour will go on. 111 Active-Treatment of Control Group
Experimental Group Spontaneous Amniotomy At presentation, the amniotic membranes will be left intact and labour allowed to progress, if there is however slowprogress of labour ( cervical dilatation of 1cm or less, artificial rupture of membranes will be done and labour management will continue actively. Six months At presentation, the amniotic membranes will be left intact and labour allowed to progress, if there is however slow progress of labour ( cervical dilatation of 1cm or less), artificial rupture of membranes will be done, augmentation of labour will be commenced as appropriate and labour management will continue actively. If however, the progress of labour is adequate with a cervical dilatation of greater than 1cm, the amniotic membranes will be left intact till shortly before delivery of the baby at cervical dilatation of 10cm. if the membranes get ruptured spontaneously during the course of labour, the time at which this occur will be taken note of. 111
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
. Consenting pregnant women with spontaneous labour at gestational age of between 37weeks and 41weeks 6days. . Live singleton fetus with vertex presentation . Patients with intact membranes at presentation in labour . Cervical dilatation of 4cm-5cm at presentation . Ruptured membranes . Obstetric and medical complications such as antepartum hemorrhage, hypertensive disorders in pregnancy, diabetes in pregnancy . Malpresentation . Multiple pregnancy . Gestational age < 37completed weeks/ > 42 completed weeks . Contraindications to vaginal delivery . HIV positive patients and those with unknown HIV status . Intrauterine fetal death. . Previous caesarean section scar . Diagnosis of congenital anomaly in the fetus. . Meconium stained liquor 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 29/03/2023 UITH Ethical Research 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 the duration of labour from first vaginal examination in active phase of labour to delivery of the baby, rate of cervical os dilatation and the need for augmentation with oxytocin and dosage of oxytocin required. The duration of labour will measured at delivery of the baby, dose of oxytocin required will be measured when there is adequat
Secondary Outcome The secondary outcome measures will be the incidence of fetal heart rate abnormalities, mode of delivery, neonatal outcome using the APGAR scores at 1 and 5 minutes and admission into neonatal unit. The Caesarean section rates for both groups will be calculated and compared. Mode of delivery will be known at delivery of the baby, APGAR scores of the baby will be determined at 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 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 08034276724 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 08033813442 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 Grace Ezeoke graceaustin2004@yahoo.com 08033823206 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 Patients who consent and participate in this research will not be individually identified in the reports or publications that will arise from the study Study Protocol 12 months open access
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