|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
PACTR |
|
Last refreshed on:
|
29 May 2023 |
|
Main ID: |
PACTR201502001034448 |
|
Date of registration:
|
13/02/2015 |
|
Prospective Registration:
|
Yes |
|
Primary sponsor: |
|
|
Public title:
|
The Gentle Assisted Pushing Study
|
|
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. |
|
Date of first enrolment:
|
16/02/2015 |
|
Target sample size:
|
1145 |
|
Recruitment status: |
Pending |
|
URL:
|
https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=1034 |
|
Study type:
|
Interventional |
|
Study design:
|
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
|
|
Phase:
|
Not Applicable
|
|
|
Countries of recruitment
|
|
South Africa
| | | | | | | |
|
Contacts
|
|
Name:
|
Justus
Hofmeyr |
|
Address:
|
Effective Care Research Unit (ECRU)*, Cecelia Makiwane Hospital, P/Bag X 13003,
5207
Cambridge
South Africa |
|
Telephone:
|
+27 83 280 9402 |
|
Email:
|
justhof@gmail.com |
|
Affiliation:
|
Director |
|
|
Name:
|
Mandisa
Singata |
|
Address:
|
Effective Care Research Unit (ECRU)*, Cecelia Makiwane Hospital, P/Bag X 13003
5207
Cambridge
South Africa |
|
Telephone:
|
+27 82 420 1743 |
|
Email:
|
mandisa.singata@gmail.com |
|
Affiliation:
|
Deputy Director |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria: ¿ 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
Exclusion criteria: ¿ 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
Age minimum:
18 Year(s)
Age maximum:
49 Year(s)
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Pregnancy and Childbirth
|
|
Delayed second stage of labour
|
Pregnancy and Childbirth
Delayed second stage of labour
|
|
Intervention(s)
|
|
Upright posture
|
|
GAP (gentle fundal pressure in an upright posture)
|
|
Upright posture only
|
|
|
|
Primary Outcome(s)
|
|
Mean time from randomization to delivery
|
|
Secondary ID(s)
|
|
WHO : A65866
|
|
Source(s) of Monetary Support
|
|
WHO
|
|
Ethics review
|
Status: Approved
Approval date:
Contact:
University of Witwatersrand :Human Research Ethics Committe(Medical)
|
Status: Approved
Approval date:
Contact:
WHO :Reesarch Ethics Review Committee
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|