Making birthing safe for women in Pakistan
| ISRCTN | ISRCTN86264432 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86264432 |
| Secondary identifying numbers | RAF/LG/DTL/18-6/20 |
- Submission date
- 16/05/2011
- Registration date
- 01/07/2011
- Last edited
- 14/06/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Plain English summary of protocol
Background and study aims
In Pakistan, deaths of mothers and newborns are still at a level considered high for the country. The Maternal, Neonatal and Child Health (MNCH) programme has been launched with five key strategic components. Improved availability and use of skilled birth attendants, and emergency obstetric and neonatal care through strengthened primary health care facilities are the two key approaches to making birthing safe. A nationwide network of about 100,000 lady health workers is already involved in antenatal and postnatal care of pregnant women. They also act as “gatekeepers” for the child birthing services. This gatekeeping role mainly includes counseling and referral for skill birth attendance and travel arrangements for emergency obstetric care (if required). The review of current arrangements and practices shows that the care delivery process needs improvement to include adequate information provision as well as informed decision making and planned action taking by pregnant women. The two interventions to be tested in this study are: enabling the pregnant women and families to plan and prepare for safe birth (i.e. address the delay in decision-making); and mobilizing the communities to arrange travel for emergency obstetric care (i.e. address the delay in timely access). The aim of this study is to assess whether these interventions increase the use of safe birthing services and reduces the newborn mortality (death) rate.
Who can participate?
Primary healthcare facilities in three selected districts of Punjab (Jhang, Chiniot and Khanewal)
What does the study involve?
Participating healthcare facilities are randomly allocated into three groups. Pregnant women in group 1 are given interventions to address decision delays plus access delays. Those in group 2 are given interventions to address decision delays only. Group 3 receive routine care. A total of 75,600 pregnancies in the three groups are followed up for their birthing practices and pregnancy outcomes.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Primary healthcare facilities in three selected districts of Punjab (Jhang, Chiniot and Khanewal) (Pakistan)
When is the study starting and how long is it expected to run for?
February 2011 to May 2013
Who is funding the study?
Research & Advocacy Fund (Pakistan)
Who is the main contact?
Dr Muhammad Amir Khan
Contact information
Scientific
12, Street 48
F-7/4
Islamabad
44000
Pakistan
Study information
| Study design | Cluster randomized three arm controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Cluster randomised trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Making birthing safe for women in Pakistan a cluster randomized controlled trial |
| Study objectives | Structured planning for safe birthing and effective Emergency Obstetric & Newborn Care (EmONC) services and/or travel facilitation in Pakistan, facilitated mainly through female health workers will reduce the neonatal mortality rate |
| Ethics approval(s) | National Bioethics Committee (NBC) Pakistan, 16/08/2010, ref: 4-87/10/NBC-39/RDC/487 |
| Health condition(s) or problem(s) studied | Maternal, neonatal and child health |
| Intervention | 1. Arm 1: structured planning for safe birthing/EmONC 2. Arm 2: structured planning for safe birthing/EmONC plus transport facilitation 3. Arm 3: no transport facilitation or structured birth planning-education for safe birthing/EmONC (current/routine practice) |
| Intervention type | Other |
| Primary outcome measure | Neonatal mortality rate (NMR) |
| Secondary outcome measures | Neonatal morbidity rates |
| Overall study start date | 01/02/2011 |
| Completion date | 31/05/2013 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 75,600 total pregnancies will be recruited, 25,200 pregnancies in each of the three arms |
| Key inclusion criteria | 1. Elibility criteria for population is the availability of safe birthing and EmONC services (made available through the Maternal Newborn and Child Health (MNCH) Programme) and a functioning network of lady health workers (through the National Programme for Primary Health Care and Family Planning) 2. All pregnancies in the selected clusters will be eligible |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/02/2011 |
| Date of final enrolment | 31/05/2013 |
Locations
Countries of recruitment
- Pakistan
Study participating centre
44000
Pakistan
Sponsor information
Research council
23A Street 8
F-7/3
Islamabad
44000
Pakistan
| Website | http://www.rafpakistan.org/ |
|---|---|
"ROR" |
https://ror.org/05rf29967 |
Funders
Funder type
Research council
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 15/07/2012 | Yes | No |
Editorial Notes
14/06/2017: Plain English summary added.
