Postpartum HemorrhagePhase 3CCTNCT00781066
Controlled Cord Traction During Third Stage of Labor
A Phase 3 study of Postpartum Hemorrhage, run by Universidad de la Republica at 2 sites in Uruguay.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesUruguay
- Study dates
- Jan 2007to Sep 2007
- Phase
- Phase 3
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years old or more
- Single pregnant women during third trimester of prenatal care or in early first stage of labor at the participating hospital (Cervical dilatation ≤ 6 cm).
- No indication of cesarean section
- No contraindications for receiving prophylactic uterotonics
- Gestational age ≥ 37 weeks
- Additional Inclusion Criteria for Randomization
- Imminent vaginal delivery
Who cannot join
- Severe acute complications during labor requiring emergency actions (e.g., eclampsia, hemorrhage, or any other complications that imply serious difficulties according to the judgment of the attendant)
- No consent to participate in the study
Trial locations and contacts
2 sites in 1 country.
Uruguay2 sites
Clinica's Hospital Manuel Quintela of the University of the Republic of Uruguay
Montevideo, Montevideo Department, 11600
Pereira Rossell Hospital
Montevideo, Montevideo Department, 11600
About this study
Official title: Controlled Cord Traction During Third Stage of Labor: Pilot Trial
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:
- In women having term, single vaginal deliveries in hospital settings, in whom the third stage is managed with prophylactic oxytocin, does CCT produce a clinically significant reduction in the incidence of postpartum blood lose?
- In these women, does CCT produce a clinically significant increase in the incidence of severe complications, including uterine inversion or the need for subsequent surgical evacuation of retained placental tissues and membranes (curettage or manual removal)?
To answer these two questions we designed two arms randomized controlled trial.
Read the detailed description
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.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Controlled cord traction, No controlled cord traction
- Keywords
- POSTPARTUM HEMORRHAGE, PREVENTION, CORD TRACTION, THIRD STAGE LABOR
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled cord tractionProcedure or surgery
- Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn), hold it in one hand.
- Place the other hand just above the woman's pubic bone and stabilize the uterus by applying counter-pressure during controlled cord traction.
- Keep slight tension on the cord and await a strong uterine contraction (2-3 minutes).
- 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.
- 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.
No controlled cord tractionProcedure or surgery
- Clamp the cord close to the perineum (once pulsation stops, or after three minutes in a healthy newborn).
- 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).
- After separation, delivery of the placenta will be aided only by maternal expulsive efforts and/or gravity.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Controlled cord traction (CCT) Receives: Procedure: Controlled cord traction |
| 2 | Active comparator | No CCT Receives: Procedure: No controlled cord traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postpartum blood loss
Measured: a minimum of 20 minutes after delivery
Secondary outcomes (5)
Manual removal of placenta
Measured: within 1 hour after delivery
Uterine inversion
Measured: within 30 minutes after delivery
Uterine curettage
Measured: before hospital discharge
Blood transfusion
Measured: before Hospital discharge
Length of third stage of labor (minutes)
Measured: until expulsion of the placenta
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad de la Republica
- Sponsor type
- University, hospital or other
- Collaborators
- Unidad de Investigación Clínica y Epidemiológica Montevideo, Institute for Clinical Effectiveness and Health Policy
- Investigators
- Alicia V Aleman, MD, Principal investigator, Unidad de Investigación Clínica y Epidemiológica Montevideo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781066
- Sponsor's protocol ID
- CCT 06-00051
- Other IDs
- D43TW005492 (NIH grant number), D43TW005492
- Acronym
- CCT
- Status last verified
- Oct 2008
- First submitted
- 27 Oct 2008
- Last updated
- 28 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carvalho JF, Piaggio G, Wojdyla D, Widmer M, Gulmezoglu AM. Distribution of postpartum blood loss: modeling, estimation and application to clinical trials. Reprod Health. 2018 Dec 4;15(1):199. doi: 10.1186/s12978-018-0641-1.
PubMed 30514326Piaggio G, Carvalho JF, Althabe F. Prevention of postpartum haemorrhage: a distributional approach for analysis. Reprod Health. 2018 Jun 22;15(Suppl 1):97. doi: 10.1186/s12978-018-0530-7.
PubMed 29945633
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Controlled Cord Traction During Third Stage of Labor: Pilot Trial
- ClinicalTrials.gov ID
- NCT00781066
- Acronym / sponsor ID
- CCT / CCT 06-00051
- Conditions
- Postpartum Hemorrhage
- Keywords
- POSTPARTUM HEMORRHAGE, PREVENTION, CORD TRACTION, THIRD STAGE LABOR
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Universidad de la RepublicaUniversity, hospital or other
- Collaborators
- Unidad de Investigación Clínica y Epidemiológica Montevideo, Institute for Clinical Effectiveness and Health Policy
- Study start
- Jan 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Oct 2008 (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.
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:
- In women having term, single vaginal deliveries in hospital settings, in whom the third stage is managed with prophylactic oxytocin, does CCT produce a clinically significant reduction in the incidence of postpartum blood lose?
- In these women, does CCT produce a clinically significant increase in the incidence of severe complications, including uterine inversion or the need for subsequent surgical evacuation of retained placental tissues and membranes (curettage or manual removal)?
To answer these two questions we designed two arms randomized controlled trial.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Controlled cord tractionControlled cord traction (CCT) |
| 2 | Active comparator | Procedure: No controlled cord tractionNo CCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years old or more
- Single pregnant women during third trimester of prenatal care or in early first stage of labor at the participating hospital (Cervical dilatation ≤ 6 cm).
- No indication of cesarean section
- No contraindications for receiving prophylactic uterotonics
- Gestational age ≥ 37 weeks
Key exclusion criteria (2 listed)
- Severe acute complications during labor requiring emergency actions (e.g., eclampsia, hemorrhage, or any other complications that imply serious difficulties according to the judgment of the attendant)
- No consent to participate in the study
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 |
|---|---|---|
| Controlled cord traction1. 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. | Procedure or surgery | 1 |
| No controlled cord traction1. 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. | Procedure or surgery | 2 |
Primary outcome
Postpartum blood loss
Time frame: a minimum of 20 minutes after delivery
5 secondary outcomes
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
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 28 Oct 2008.
- Derived from this study: PubMed 30514326Carvalho JF, Piaggio G, Wojdyla D, Widmer M, Gulmezoglu AM. Distribution of postpartum blood loss: modeling, estimation and application to clinical trials. Reprod Health. 2018 Dec 4;15(1):199. doi: 10.1186/s12978-018-0641-1.
- Derived from this study: PubMed 29945633Piaggio G, Carvalho JF, Althabe F. Prevention of postpartum haemorrhage: a distributional approach for analysis. Reprod Health. 2018 Jun 22;15(Suppl 1):97. doi: 10.1186/s12978-018-0530-7.
- School of Medicine of the University of the RepublicLink provided by the sponsor.
- Clinical and Epidemiological Research Unit MontevideoLink provided by the sponsor.
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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.
Alicia V Aleman, MD principal investigator
Unidad de Investigación Clínica y Epidemiológica Montevideo
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study of Postpartum Hemorrhage, run by Universidad de la Republica at 2 sites 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 7 inclusion and 2 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 28 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Postpartum blood loss (time frame: a minimum of 20 minutes after delivery). 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 NCT00781066, which also lists 2 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 28 Oct 2008.