A Phase 3 interventional study of Controlled cord traction and No controlled cord traction in Postpartum Hemorrhage, sponsored by Universidad de la Republica. Completed at 2 sites in Uruguay. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-10-28.
Sponsored by Universidad de la Republica · Phase 3, Interventional, and Prevention
Of the estimated number of 529,000 maternal deaths for the year 2000, 132,000 (25%) were caused by postpartum hemorrhage (PPH); 99% of these deaths occurred in low-income countries. Where maternal mortality is high and resources are limited, the introduction of low-cost, evidence-based practices for primary prevention of PPH is an urgent need. Controlled cord traction (CCT) is actively promoted in combination with prophylactic uterotonics for the prevention of PPH. While the administration of uterotonics has been proven effective, there is no evidence of CCT being beneficial or safe. The investigators propose this study to evaluate two primary questions:
To answer these two questions we designed two arms randomized controlled trial.
Subjects This study will be conducted in two Public Hospital from Montevideo, Uruguay. A total of 200 women (100 by group) will be recruited.
Description of the Study Design This will be a two-arm, randomized controlled clinical trial in which 200 women having a single vaginal delivery and receiving prophylactic oxytocin for the management of the third stage of labor at two public hospital in Montevideo will be allocated to one of two interventions: CCT or a "hands-off" policy. All outcomes will be measured before maternal discharge from the hospital. The primary outcome is postpartum blood loss.
Duration of the Study We estimate that we will need a total of 11 months to complete this study. Three months will be needed for preparation (installing data collection resources and training data collectors and birth attendants), and 6 months for recruitment, and two months for data analysis and preparation of reports and manuscripts.
Where Subjects Are/ Study Site and Populations The study will be conducted in two public hospitals from Montevideo, Uruguay. These are third level public hospitals supported by the University of the Republic, with a total of 9,900 deliveries per year.
Full Description of Risks There is no evidence to suggest that there were risks from this study to the women or the newborns, because it is not known if CCT is associated with serious complications in the mother. In all previous active management trials and in the two CCT trials, there were no reported cases of uterine inversion, and currently, CCT is the recommended standard of care during delivery. In theory, the most severe potential complication is uterine inversion, which can be a life-threatening condition if adequate care is not provided. However, this event is unlikely with the simultaneous use of uterotonics to assure a well contracted uterus and eventually, it can be successfully managed in hospital settings.
Benefits for Subjects and/or Society:
We do not expect a clinical and important benefit from this study at an individual level of the pregnant women. However, this study will provide useful information to evaluate one specific intervention recommended for the management of third stage of labor.
Inducement for Participants:
No monetary inducement will be offered to the participants.
Costs to Subjects: N/A
Statistical Analysis Before addressing the research question, descriptive statistics and summary graphics such as histograms will be prepared and examined for outcomes and demographic variables. All analyses addressing the study research questions will use the "intention to treat" principle, thus comparing the original intervention group to the original nonintervention group, even if individuals have withdrawn from the study or shifted to another group. The analysis plan and presentation of results will follow the recommendation of the CONSORT statement. In this study the primary outcome is continues (blood loss), therefore, median and inter-quartile ranges will be computed as part of descriptive data analysis to understand the distribution of the outcome variables and to assess the need of data transformation or adoption of nonparametric tests, including Mann-Whitney U tests. Means for the two groups will be compared by the two-sample t-test. A similar analysis will be performed for the duration (in minutes) of the third stage of labor.
Methods of Recruitment:
Enrollment will be done during and previous to women's labor at the maternity. Screening will start at the time of admission and when possible during prenatal care, and for those eligible women, a signed consent form will be required. Sealed envelopes opened just before delivery(at delivery guard) will be used to determine whether the woman should receive CCT or not. A random allocation scheme will be derived from a computer-generated list of numbers, with randomly permuted blocks.
Informed Consent Services directors will provide written authorization to participate in this study. Individual birth attendants will receive an information sheet describing the objectives of the study and including the name and phone number of the study coordinator. Birth attendants will also be invited to participate in the training workshops. Women will be invited to participate upon admission to the hospital (or during prenatal care when possible) and, if they agree to participate, will provide written informed consent to their birth attendant. The birth attendant will then be required to disclose to the patient all of the facts about the nature of the trial, interventions under comparison, the risks involved, available alternatives and their risk, and reasonable expectations for the treatment outcome. This study was submitted to the Institutional Review Board of the School of Medicine, University of Uruguay for approval and the Institutional Review Board of Tulane University . The PI and co-PI have attended training sessions on the protection of human subjects and have been certified by the Institutional Review Boards at their institutions. The coordinator and research assistant invited to participate in this study will be asked to complete an on-line training session on protection of human subjects.
469 studies on the registry are indexed under Postpartum Hemorrhage; 76 are open to participants now.
This study's enrollment of 200 is above the median of 148 across 360 interventional studies indexed under Postpartum Hemorrhage.
Browse Postpartum Hemorrhage studies →Universidad de la Republica is the lead sponsor of 8 studies on the registry; none are open to participants now.
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Additional Inclusion Criteria for Randomization
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Controlled cord traction (CCT)
Procedure: Controlled cord traction
No CCT
Procedure: No controlled cord traction
1. Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn), hold it in one hand. 2. Place the other hand just above the woman's pubic bone and stabilize the uterus by applying counter-pressure during controlled cord traction. 3. Keep slight tension on the cord and await a strong uterine contraction (2-3 minutes). 4. With the strong uterine contraction, encourage the mother to push and very gently pull downward on the cord to deliver the placenta. Continue to apply counter-pressure to the uterus. 5. If the placenta does not descend during 30-40 seconds of CCT, do not continue to pull on the cord: * Gently hold the cord and wait until the uterus is well contracted again; * With the next contraction, repeat CCT with counter-pressure.
1. Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn). 2. No CCT will be used and no fundal pressure. The placenta will be delivered physiologically, and signs for placental separation will be awaited (gush of blood from the vagina, descent of the umbilical cord, and increase in the height of the uterus in the abdomen as the lower segment was distended). 3. After separation, delivery of the placenta will be aided only by maternal expulsive efforts and/or gravity.
Postpartum blood loss
Time frame: a minimum of 20 minutes after delivery
Manual removal of placenta
Time frame: within 1 hour after delivery
Uterine inversion
Time frame: within 30 minutes after delivery
Uterine curettage
Time frame: before hospital discharge
Blood transfusion
Time frame: before Hospital discharge
Length of third stage of labor (minutes)
Time frame: until expulsion of the placenta
The record gives a start of Jan 2007, a primary completion of Sep 2007 and a completion of Sep 2007. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.
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Universidad de la Republica