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.: PACTR202305811094904 Date of Approval: 09/05/2023
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title 4cm vs 5cm vs 6cm active phase of labour trial
Official scientific title A comparison of labour progress and pregnancy outcomes in nulliparous women in whom diagnosis of active phase labour was based on 4cm, 5cm and 6cm cervical dilatation: A randomized controlled trial
Brief summary describing the background and objectives of the trial The 4cm benchmark for diagnosis of active phase labour has remained the cut-off for most centres that offer maternity care until criticisms from recent studies came up showing that most women especially nulliparas were not fully in active phase of labour by 4cm with suggestions for a new diagnosis of active phase of labour at either 5cm or 6cm . This may not only reduce the rate of unwanted intervention in an uncomplicated labour but also reduce primary and repeat caesarean section rates with their attendant complications and cost implication. The aim of this trial is to compare labour progress patterns and pregnancy outcomes at active phase of labour using 4cm, 5cm and 6cm cervical dilatation as cut off in nulliparous women.
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 Diagnosis / Prognosis
Anticipated trial start date 15/05/2023
Actual trial start date
Anticipated date of last follow up 07/08/2023
Actual Last follow-up date
Anticipated target sample size (number of participants) 132
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table created by a computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group 4cm cervical dilatation as time of commencement of active phase of labour 4cm cervical dilatation as time of commencement of active phase of labour Vaginal examination/cervical assessment every four hours unless otherwise indicated till achievement of full cervical dilatation and subsequent delivery of the fetus Nulliparous parturients in spontaneous labour who met the inclusion criteria and consented to this study will be recruited. Initial assessment of subjects will include a sterile vaginal examination to select parturients with cervical dilatation of 4cm who will be enrolled into the study. Randomization will be achieved using a computer generated random number table permuted in blocks of 6 with a 1:1:1 ratio. Group assignments will be kept in the labour ward in sequentially numbered and sealed opaque envelopes that were opened after obtaining consent. Those in Group A(4cm) at admission into labour ward will be managed according to the departmental protocol for active management of labour (AML) and data will be recorded on the partograph 44 Active-Treatment of Control Group
Experimental Group 5cm cervical dilatation as time of commencement of active phase of labour 5cm cervical dilatation as time of commencement of active phase of labour. Vaginal examination/cervical assessment every four hours unless otherwise indicated till achievement of full cervical dilatation and subsequent delivery of the fetus. Nulliparous parturients in spontaneous labour who met the inclusion criteria and consented to this study will be recruited. Initial assessment of subjects will include a sterile vaginal examination to select parturients with cervical dilatation of 4cm who will be enrolled into the study. Randomization will be achieved using a computer generated random number table permuted in blocks of 6 with a 1:1:1 ratio. Group assignments will be kept in the labour ward in sequentially numbered and sealed opaque envelopes that were opened after obtaining consent. Those in Group B(5cm) will be considered to be in latent phase of labour when admitted at 4cm cervical dilatation. They will be managed as cases of latent phase of labour with regular fetal and maternal vitals monitoring. Vaginal examinations will be repeated hourly to determine those who have attained the experimental study active phase of either 5cm cervical dilatation. They will then have amniotomy done and subsequent management with the partograph and AML protocol as in Group A. 44
Experimental Group 6cm cervical dilatation as time of commencement of active phase of labour 6cm cervical dilatation as time of commencement of active phase of labour Vaginal examination/cervical assesment is done every four hours unless otherwise indicated till achievement of full cervical dilatation and subsequent delivery of the fetus. Nulliparous parturients in spontaneous labour who met the inclusion criteria and consented to this study will be recruited. Initial assessment of subjects will include a sterile vaginal examination to select parturients with cervical dilatation of 4cm who will be enrolled into the study. Randomization will be achieved using a computer generated random number table permuted in blocks of 6 with a 1:1:1 ratio. Group assignments will be kept in the labour ward in sequentially numbered and sealed opaque envelopes that were opened after obtaining consent. Those in Group C(6cm) will be considered to be in latent phase of labour when admitted at 4cm cervical dilatation. They will be managed as cases of latent phase of labour with regular fetal and maternal vitals monitoring. Vaginal examinations will be repeated hourly to determine those who have attained the experimental study active phase of 6cm cervical dilatation. They will then have amniotomy done and subsequent management with the partograph and active management of labour protocol as in Group A. 44
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
1. Willingness and consent to participate in the study 2. Nulliparity 3. Singleton viable intrauterine pregnancy 4. Term gestation (37-42weeks) 5. Active phase of labour (4cm or 5cm or 6cm) 6. Intact membranes 7. Cephalic presentation 1. Any contraindication to vaginal delivery 2. Multiple pregnancy 3. Ruptured membrane 4. Multiparas 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 15/12/2022 Research and Ethics Committe of the Federal Medical Centre Asaba
Ethics Committee Address
Street address City Postal code Country
Nnebisi Road Asaba Delta State Asaba 320213 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The Primary outcome measure will be the rate of cervical dilatation in each arm of the study Four hourly vaginal examination unless otherwise stated
Secondary Outcome The Secondary outcome measures will include route of delivery, duration of active phase of labour, duration of first, second and third stages of labour, augmentation rate, incidence of post-partum haemorrhage, occurrence of retained placenta, perineal tear incidence, Apgar score at 1 and 5minute and need for neonatal admission. Four hourly vaginal examination or more frequently if indicated up to full cervical dilatation, second stage of labour, third stage of labour, one hour after delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Federal Medical Centre Asaba Delta State Nigeria Nnebisi Road, Asaba Delta State Asaba 320213 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Dr Ilikannu Samuel Okwuchukwu 2 Uche Iwunor Street Behind City Complex Off Nnebisi Road Asaba, Delta State Asaba Delta State Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor DR ILIKANNU SAMUEL OKWUCHUKWU 2 UCHE IWUNOR STREET BEHIND CITY COMPLEX, OFF NNEBISI ROAD ASABA Asaba 320213 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
Prof Peter Ndidi Ebeigbe Ugbowo road Benin Nigeria
Dr Taiwo Olagoke Dunsin Nnebisi Road Asaba Asaba Nigeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator SAMUEL ILIKANNU dr.ilikannu@gmail.com +2348038411984 2 Uche Iwunor Street, Behind City Complex, Off Nnebisi Road, Asaba
City Postal code Country Position/Affiliation
Asaba Nigeria Senior Resident
Role Name Email Phone Street address
Public Enquiries SAMUEL ILIKANNU dr.ilikannu@gmail.com +2348038411984 2 Uche Iwunor Street Behind City Complex, Off Nnebisi Road, Asaba
City Postal code Country Position/Affiliation
Asaba Nigeria Senior Resident
Role Name Email Phone Street address
Scientific Enquiries PETER EBEIGBE peternebeigbe@gmail.com +2348035649146 Ugbowo Road
City Postal code Country Position/Affiliation
Benin Nigeria Professor of Obstetrics and Gynaecology and Consultant Obstetrician and Gynaecologist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual patient data (IPD) will be shared after deidentification of all data collected Informed Consent Form,Statistical Analysis Plan,Study Protocol December 2023 to April 2024 Open
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