EpisiotomyPhase 4NCT00070720
Improving Perinatal Care in Latin America
A Phase 4 study testing Opinion Leaders, Academic Detailing, Reminders, and Feedback in people with Episiotomy and Pregnancy, run by NICHD Global Network for Women's and Children's Health at 1 site in Uruguay.
Trial summary
Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Episiotomy, Pregnancy
- What is being tested?
- Opinion Leaders, Academic Detailing, Reminders, and Feedback
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21,780 participants
- Where
- 1 siteUruguay
- Study dates
- Sep 2003to Dec 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hospitals were invited to participate in the study if they fulfill the following criteria:
- have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
- have at least 500 vaginal deliveries per year;
- do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
- are located within the study area in Argentina and Uruguay; and
- agree to participate in the study.
Who cannot join
- Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:
- Episiotomy rate in spontaneous vaginal deliveries below 20%
- Rate of active management of third stage of labor over 25%
- The sample size of the study was increased to allow for exclusions.
- Expectant management is defined as "a hands-free policy" during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.
- Sampling, Recruitment, and Screening Procedures
Show all 12Show fewer
- Latin American Center for Perinatology (CLAP) coordination team will be responsible for the hospital selection. The hospitals' fulfillment of selection criteria will be obtained through a survey of the Heads of the Obstetrical Departments.
- Besides the selection criteria, the coordination unit will invite the hospitals to participate according to:
- their participation in previous trials coordinated by CLAP,
- their participation in other trials or research activities, and
- their location.
- Of particular interest are the characteristics of each preselected hospital regarding the structure of the professional staff, number of deliveries, and clinical guidelines policy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.
Read the detailed description
In Latin American countries certain procedures commonly used in obstetrical care (e.g. episiotomy) have been shown to be ineffective or harmful. This study hypothesizes that obstetrical procedures can be changed and new guidelines implemented via peer opinion leader training. It tests an intervention designed to motivate and facilitate health care professionals' development through the implementation and maintenance of simple evidence-based guidelines to increase the use of evidence-based practices by birth attendants at the hospital level in Argentina and Uruguay. The primary outcomes are the use of episiotomies and of oxytocin during the third stage of labor; secondary outcomes include perineal sutures; postpartum hemorrhages; birth attendants' readiness to change status. The sample size was based upon a 10% frequency of oxytocin use and 20% use of episiotomies in the control group. The study hypothesizes a 40% absolute increase in oxytocin use in the intervention group; a 20% absolute reduction in use of episiotomies in the intervention group, calculated at a 0.05 significance level with 80% power.
Following baseline data collections in 24 hospitals, 19 hospitals met inclusion criteria in three urban districts of Argentina and Uruguay and were randomly assigned to an intervention or control group. Baseline data collection has been completed with a total of 6597 single vaginal spontaneous births. The 19 hospitals met inclusion criteria with a rate of active management of third stage of labor under 25% and an episiotomy rate in spontaneous vaginal deliveries above 20%. Opinion leaders in the intervention hospitals have been identified and trained to develop evidence-based guidelines that will be diffused by a multifaceted approach including seminars, academic detailing, reminders, and feedback on utilization rates. The hospitals in the nonintervention group will continue with their standard in-service training activities.
- Conditions
- Episiotomy, Pregnancy
- Being tested
- Opinion Leaders, Academic Detailing, Reminders, and Feedback
- Keywords
- Behavior change, Change in practitioner behavior, Episiotomy, Active management of third stage of labor, Global Network, Latin America, Uruguay, Argentina, Maternal and child health, International, Women's health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opinion Leaders, Academic Detailing, Reminders, and FeedbackBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Episiotomies
Oxytocin use in third stage of labor
Secondary outcomes (3)
Perineal sutures
Postpartum hemorrhage
Birth attendants' readiness to change status
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2003 (estimated)
- Study startSep 2003
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for EpisiotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21,780 participants
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, Latin American Center for Perinatology, Pan American Health Organization, World Health Organization, Tulane University School of Public Health and Tropical Medicine, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
- Investigators
- Pierre Buekens, MD, PhD, Principal investigator, Tulane School of Public Health and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00070720
- Sponsor's protocol ID
- GN 01
- Other IDs
- U01HD040477
- Status last verified
- Dec 2013
- First submitted
- 7 Oct 2003
- Last updated
- 17 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Althabe F, Buekens P, Bergel E, Belizan JM, Kropp N, Wright L, Goco N, Moss N; for the Guidelines Trial Group. A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627]. BMC Womens Health. 2005 Apr 11;5(1):4. doi: 10.1186/1472-6874-5-4.
PubMed 15823211Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. Int J Gynaecol Obstet. 2005 Nov;91(2):157-9. doi: 10.1016/j.ijgo.2005.07.013. Epub 2005 Oct 5. No abstract available.
PubMed 16169552Althabe F, Buekens P, Bergel E, Belizan JM, Campbell MK, Moss N, Hartwell T, Wright LL; Guidelines Trial Group. A behavioral intervention to improve obstetrical care. N Engl J Med. 2008 May 1;358(18):1929-40. doi: 10.1056/NEJMsa071456.
PubMed 18450604
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clustered Trial for Improving Perinatal Care in Uruguay/Argentina
- ClinicalTrials.gov ID
- NCT00070720
- Acronym / sponsor ID
- GN 01
- Conditions
- Episiotomy, Pregnancy
- Keywords
- Behavior change, Change in practitioner behavior, Episiotomy, Active management of third stage of labor, Global Network, Latin America, Uruguay, Argentina
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21,780 participants
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, National Center for Complementary and Integrative Health (NCCIH), National Institute of Dental and Craniofacial Research (NIDCR), National Cancer Institute (NCI), RTI International, Latin American Center for Perinatology, Pan American Health Organization, World Health Organization, Tulane University School of Public Health and Tropical Medicine, University of North Carolina, Chapel Hill
- Study start
- Sep 2003
- Study completion
- Dec 2006 (actual)
- First posted
- 13 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many obstetrical interventions used in Latin America, as in other parts of the world, have been shown to be ineffective or harmful, while effective interventions remain underutilized. This study will develop and evaluate an intervention intended to implement two evidence-based practices among birth attendants in Latin America, the selective use of episiotomies and active management of the third stage of labor.
Detailed description
In Latin American countries certain procedures commonly used in obstetrical care (e.g. episiotomy) have been shown to be ineffective or harmful. This study hypothesizes that obstetrical procedures can be changed and new guidelines implemented via peer opinion leader training. It tests an intervention designed to motivate and facilitate health care professionals' development through the implementation and maintenance of simple evidence-based guidelines to increase the use of evidence-based practices by birth attendants at the hospital level in Argentina and Uruguay. The primary outcomes are the use of episiotomies and of oxytocin during the third stage of labor; secondary outcomes include perineal sutures; postpartum hemorrhages; birth attendants' readiness to change status. The sample size was based upon a 10% frequency of oxytocin use and 20% use of episiotomies in the control group. The study hypothesizes a 40% absolute increase in oxytocin use in the intervention group; a 20% absolute reduction in use of episiotomies in the intervention group, calculated at a 0.05 significance level with 80% power.
Following baseline data collections in 24 hospitals, 19 hospitals met inclusion criteria in three urban districts of Argentina and Uruguay and were randomly assigned to an intervention or control group. Baseline data collection has been completed with a total of 6597 single vaginal spontaneous births. The 19 hospitals met inclusion criteria with a rate of active management of third stage of labor under 25% and an episiotomy rate in spontaneous vaginal deliveries above 20%. Opinion leaders in the intervention hospitals have been identified and trained to develop evidence-based guidelines that will be diffused by a multifaceted approach including seminars, academic detailing, reminders, and feedback on utilization rates. The hospitals in the nonintervention group will continue with their standard in-service training activities.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Hospitals were invited to participate in the study if they fulfill the following criteria:
- have an Institutional Review Board (IRB), or existing committee which could serve as such, or have an agreement with an IRB which reviews the research protocols implemented in the hospital;
- have at least 500 vaginal deliveries per year;
- do not have an explicit policy for selective episiotomy and for active management of third stage of labor;
- are located within the study area in Argentina and Uruguay; and
Key exclusion criteria (12 listed)
- Preselected hospitals are performing baseline data collection. According to the results of the analysis of the baseline data collection, hospitals will be excluded if the episiotomy rate is low or the rate of active management of the third stage of labor is high, according to the following cut-off points:
- Episiotomy rate in spontaneous vaginal deliveries below 20%
- Rate of active management of third stage of labor over 25%
- The sample size of the study was increased to allow for exclusions.
- Expectant management is defined as "a hands-free policy" during third stage of labor until the placenta is expelled: no use of uterotonics or special maneuvers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opinion Leaders, Academic Detailing, Reminders, and Feedback | Behavioural | – |
Primary outcome
Episiotomies
Oxytocin use in third stage of labor
3 secondary outcomes
Perineal sutures
Postpartum hemorrhage
Birth attendants' readiness to change status
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2013.
- Background: PubMed 15823211Althabe F, Buekens P, Bergel E, Belizan JM, Kropp N, Wright L, Goco N, Moss N; for the Guidelines Trial Group. A cluster randomized controlled trial of a behavioral intervention to facilitate the development and implementation of clinical practice guidelines in Latin American maternity hospitals: the Guidelines Trial: Study protocol [ISRCTN82417627]. BMC Womens Health. 2005 Apr 11;5(1):4. doi: 10.1186/1472-6874-5-4.
- Background: PubMed 16169552Kropp N, Hartwell T, Althabe F. Episiotomy rates from eleven developing countries. Int J Gynaecol Obstet. 2005 Nov;91(2):157-9. doi: 10.1016/j.ijgo.2005.07.013. Epub 2005 Oct 5. No abstract available.
- Derived from this study: PubMed 18450604Althabe F, Buekens P, Bergel E, Belizan JM, Campbell MK, Moss N, Hartwell T, Wright LL; Guidelines Trial Group. A behavioral intervention to improve obstetrical care. N Engl J Med. 2008 May 1;358(18):1929-40. doi: 10.1056/NEJMsa071456.
- Tulane School of Public Health and Tropical MedicineLink provided by the sponsor.
- RTI InternationalLink provided by the sponsor.
- Institute for Clinical Effectiveness and Health Policy (IECS)Link provided by the sponsor.
Related trials for Episiotomy
Not yet recruiting
Effect of a Novel Episiotomy Repair Simulator on Midwifery Students' Self-Efficacy and Anxiety
Episiotomy Repair Training
Active, not recruitingObservational study
Novosyn® Quick in Patients Undergoing Episiotomy Closure
Episiotomy Wound
Not yet recruiting
The Effect of Skin-to-Skin Contact on Pain and Anxiety During Episiotomy Repair
Episiotomy, Pain
Not yet recruiting
The Effect of Music Play and Stress Ball Application on Placental Separation Time, Episious Pain and Breastfeeding Success
Primiparity (First-Time Mothers), Breastfeeding
Not yet recruiting
Model-Based Episiotomy Training
Episiotomy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre Buekens, MD, PhD principal investigator
Tulane School of Public Health and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Opinion Leaders, Academic Detailing, Reminders, and Feedback in people with Episiotomy and Pregnancy, run by NICHD Global Network for Women's and Children's Health at 1 site in Uruguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uruguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Episiotomies. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00070720, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2013.