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.: PACTR201502001034448 Date of Registration: 13/02/2015
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title The Gentle Assisted Pushing Study
Official scientific title The Gentle Assisted Pushing Study: a multicentre randomized controlled trial of gentle assisted pushing in the upright posture (GAP) or upright posture alone compared with routine practice to reduce prolonged second stage of labour.
Brief summary describing the background and objectives of the trial Background Fundal pressure involves the birth assistant using her hands to push on the upper part of the uterus in the direction of the birth canal to help to increase intra-uterine pressure with contractions to expel the baby. How frequently fundal pressure is performed in routine practice, and the indication for its¿ use, is unclear. There is some evidence that it may be applied routinely or to expedite delivery when this is considered desirable, e.g. for fetal distress or maternal exhaustion, particularly in developing countries where other methods of achieving delivery (forceps, vacuum) may not be available. However, there is very little objective evidence of the effectiveness or safety of this intervention. Vigorous methods of applying fundal pressure are potentially harmful. GAP is an innovative method of applying gentle but steady pressure to the uterine fundus in the direction of the pelvis during contractions, for a maximum of 30 seconds per contraction, with the woman in an upright posture. The recumbent/supine posture for the second stage of labour has become routine in health services in low-resource settings. There is some evidence that upright postures may have advantages for mother and baby, but more evidence is needed. Objectives To evaluate the use of a gentle method of applying fundal pressure in an upright posture, or upright posture alone, on reducing the mean time of delivery and the associated maternal and neonatal complications in women not having delivered following 15-30 minutes in the second stage of labour, at all levels of care.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) GAP
Disease(s) or condition(s) being studied Delayed second stage of labour,Pregnancy and Childbirth
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 16/02/2015
Actual trial start date
Anticipated date of last follow up 30/09/2015
Actual Last follow-up date
Anticipated target sample size (number of participants) 1145
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
WHO : A65866
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 This will be computer-generated in balanced blocks of variable size, in a ratio of 1:1:1 for the three study arms concealed on cards inside a sequentially-numbered series of sealed, opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group GAP (gentle fundal pressure in an upright posture) The duration of pressure will be limited to 30 seconds The woman will be assisted to assume an upright kneeling or squatting posture on the bed. The trained birth attendant will kneel behind her on the bed or stand behind her with the woman positioned at right angles to the length of the bed and back close to the side of the bed. The trained birth attendant will wrap her arms around the woman passing below her axillae, and place both open palms, over 382
Experimental Group Upright posture Participating women will be encouraged to assume an upright crouching or kneeling position during the second stage of labour. When the baby¿s head is ¿crowning¿, the trained birth attendant may choose to move the woman to a recumbent position for the birth. 382
Control Group Upright posture only 30 minutes if the woman remains undelivered 30 minutes after enrolment, fundal pressure or changes in posture may be considered necessary by the birth attendant according to routine local practice. Additional procedures or treatments performed at the discretion of the attendant will then be clearly recorded in the participants¿ records. 381 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ nulliparous women ¿ ¿18 years old ¿ singleton pregnancy ¿ cephalic fetal presentation ¿ gestational age ¿ 35 weeks vaginal delivery anticipated ¿ Undelivered following 15-30 minutes of second stage of labour ¿ chronic medical conditions, including heart disease, epilepsy, hypertension, diabetes mellitus and renal disease ¿ obstetric complications, including hypertensive disorders of pregnancy, cephalo-pelvic disproportion, antepartum haemorrhage, intra-uterine growth restriction, fetal distress, intra-amniotic infection ¿ refusal of informed consent 18 Year(s) 49 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 University of Witwatersrand :Human Research Ethics Committe(Medical)
Ethics Committee Address
Street address City Postal code Country
Private Bag 3 Johannesburg 2050 South Africa
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 WHO :Reesarch Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
20,Avenue Appia Geneva 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Mean time from randomization to delivery Delivery
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butterworth Hospital Scanlon Road Butterworth 4960 South Africa
o Cecilia Makiwane Hospital Billie Road Mdantsane 5219 South Africa
o Frere Maternity Hospital Amalinda Drive East London 5247 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
WHO 20 Avenue Appia Geneva 1211 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor World Health Organisation 20 Avenue Appia Geneva 1211 Switzerland Funding Agency
COLLABORATORS
Name Street address City Postal code Country
World Health Organisation 20 Avenue Appia Geneva 1211 Switzerland
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mandisa Singata- Madliki mandisa.singata@gmail.com +27 824201743 Frere Maternity Hospital,Amalinda drive
City Postal code Country Position/Affiliation
East London 5247 South Africa Deputy Director
Role Name Email Phone Street address
Public Enquiries Mandisa Singata mandisa.singata@gmail.com +27 82 420 1743 Effective Care Research Unit (ECRU)*, Cecelia Makiwane Hospital, P/Bag X 13003
City Postal code Country Position/Affiliation
Cambridge 5207 South Africa Deputy Director
Role Name Email Phone Street address
Scientific Enquiries Justus Hofmeyr justhof@gmail.com +27 83 280 9402 Effective Care Research Unit (ECRU)*, Cecelia Makiwane Hospital, P/Bag X 13003,
City Postal code Country Position/Affiliation
Cambridge 5207 South Africa Director
REPORTING
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