Improving perinatal care in Latin America
ISRCTN | ISRCTN82417627 |
---|---|
DOI | https://doi.org/10.1186/ISRCTN82417627 |
ClinicalTrials.gov number | NCT00070720 |
Secondary identifying numbers | GN 01 |
- Submission date
- 04/11/2004
- Registration date
- 25/02/2005
- Last edited
- 28/01/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pierre Buekens
Scientific
Scientific
School of Public Health and Tropical Medicine
Tulane University
1440 Canal St
Ste 2430
New Orleans, LA
70112
United States of America
Phone | +1 504 988 5397 |
---|---|
pbuekens@tulane.edu |
Study information
Study design | Randomised controlled trial |
---|---|
Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | A behavioral intervention to improve obstetrical care. |
Study acronym | GUIDELINES Trial |
Study objectives | The aim of this trial is to evaluate the effect of a multifaceted behavioural intervention on the use of two evidence-based birth practices, the selective use of episiotomies and active management of the third stage of labor (injection of 10 International Units of oxytocin). |
Ethics approval(s) | The protocol was submitted and approved by the IRBs of the following institutions: 1. University of North Carolina at Chapel Hill (USA) 2. Tulane University (USA) 3. Research Triangle Institute (USA) 4. Pan American Health Organization (USA) 5. School of Medicine of the University of the Republic in Uruguay (Uruguay) 6. The University Hospital of Montevideo (Uruguay) 7. The Argentinean Society for Clinical Research (Argentina) |
Health condition(s) or problem(s) studied | Episiotomy use; post-partum haemorrhage |
Intervention | Intervention group: Evidence based clinical practice guidelines development workshop for opinion leaders. Opinion leaders will then use academic detailing, reminders, and feedback for dissemination and implementation of guidelines at the hospital level. Control group: Control hospitals will continue with their usual in-service training activities and will receive components of the intervention at the end of the study period. |
Intervention type | Drug |
Pharmaceutical study type(s) | |
Phase | Not Applicable |
Drug / device / biological / vaccine name(s) | Oxytocin |
Primary outcome measure | The rates of episiotomy and oxytocin use during the third stage of labor. |
Secondary outcome measures | 1. Perineal sutures 2. Postpartum haemorrhages 3. Birth attendants opinions |
Overall study start date | 01/09/2003 |
Completion date | 01/09/2006 |
Eligibility
Participant type(s) | Patient |
---|---|
Age group | Adult |
Sex | Female |
Target number of participants | 24 public hospitals |
Key inclusion criteria | 24 public hospitals in Argentina and Uruguay that had: 1. At least 1000 vaginal deliveries per year 2. No explicit policy for selective episiotomy or active management of third stage of labor |
Key exclusion criteria | Does not comply with above inclusion criteria. |
Date of first enrolment | 01/09/2003 |
Date of final enrolment | 01/09/2006 |
Locations
Countries of recruitment
- Argentina
- United States of America
- Uruguay
Study participating centre
School of Public Health and Tropical Medicine
New Orleans, LA
70112
United States of America
70112
United States of America
Sponsor information
National Institute of Child Health and Human Development (NICHD) (USA)
Government
Government
6100 Executive Boulevard
Room 4B05H
Rockville, MD
20852
United States of America
Phone | +1 301 402 0830 |
---|---|
wrightl@mail.nih.gov | |
https://ror.org/04byxyr05 |
Funders
Funder type
Government
National Institute of Child Health and Human Development (NICHD) (USA)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- NICHD
- Location
- United States of America
Global Network for Women's and Children's Health Research (USA)
No information available
Bill and Melinda Gates Foundation (USA)
Government organisation / Trusts, charities, foundations (both public and private)
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Bill & Melinda Gates Foundation, Gates Foundation, BMGF, B&MGF, GF
- Location
- United States of America
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 | 11/04/2005 | Yes | No | |
Results article | results | 01/05/2008 | 28/01/2019 | Yes | No |
Editorial Notes
28/01/2019: Publication reference added