Condition category
Pregnancy and Childbirth
Date applied
16/05/2011
Date assigned
01/07/2011
Last edited
14/06/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr Muhammad Amir Khan

ORCID ID

Contact details

12
Street 48
F-7/4
Islamabad
44000
Pakistan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RAF/LG/DTL/18-6/20

Study information

Scientific title

Making birthing safe for women in Pakistan – a cluster randomized controlled trial

Acronym

Study hypothesis

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

National Bioethics Committee (NBC) Pakistan, 16/08/2010, ref: 4-87/10/NBC-39/RDC/487

Study design

Cluster randomized three arm controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Not Applicable

Drug names

Primary outcome measures

Neonatal mortality rate (NMR)

Secondary outcome measures

Neonatal morbidity rates

Overall trial start date

01/02/2011

Overall trial end date

31/05/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

75,600 total pregnancies will be recruited, 25,200 pregnancies in each of the three arms

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/02/2011

Recruitment end date

31/05/2013

Locations

Countries of recruitment

Pakistan

Trial participating centre

12, Street 48
Islamabad
44000
Pakistan

Sponsor information

Organisation

Research & Advocacy Fund (Pakistan)

Sponsor details

23A Street 8
F-7/3
Islamabad
44000
Pakistan

Sponsor type

Research council

Website

http://www.rafpakistan.org/

Funders

Funder type

Research council

Funder name

Research & Advocacy Fund (RAF) Ref: RAF/LG/DTL/18-6/20

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22793877

Publication citations

  1. Protocol

    Khan MA, Mirza S, Ahmed M, Rasheed A, Khan A, Walley J, Nisar N, Making birthing safe for Pakistan women: a cluster randomized trial., BMC Pregnancy Childbirth, 2012, 12, 67, doi: 10.1186/1471-2393-12-67.

Additional files

Editorial Notes

14/06/2017: Plain English summary added.