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Controlled Cord Traction During Third Stage of Labor (CCT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00781066
First Posted: October 28, 2008
Last Update Posted: October 28, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Unidad de Investigación Clínica y Epidemiológica Montevideo
Institute for Clinical Effectiveness and Health Policy
Information provided by:
Universidad de la Republica
  Purpose

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:

  1. 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?
  2. 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.


Condition Intervention Phase
Postpartum Hemorrhage Procedure: Controlled cord traction Procedure: No controlled cord traction Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Controlled Cord Traction During Third Stage of Labor: Pilot Trial

Resource links provided by NLM:


Further study details as provided by Universidad de la Republica:

Primary Outcome Measures:
  • Postpartum blood loss [ Time Frame: a minimum of 20 minutes after delivery ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 200
Study Start Date: January 2007
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Controlled cord traction (CCT)
Procedure: 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.
Active Comparator: 2
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).
  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.

  Show Detailed Description

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781066


Locations
Uruguay
Clinica's Hospital Manuel Quintela of the University of the Republic of Uruguay
Montevideo, Uruguay, 11600
Pereira Rossell Hospital
Montevideo, Uruguay, 11600
Sponsors and Collaborators
Universidad de la Republica
Unidad de Investigación Clínica y Epidemiológica Montevideo
Institute for Clinical Effectiveness and Health Policy
Investigators
Principal Investigator: Alicia V Aleman, MD Unidad de Investigación Clínica y Epidemiológica Montevideo
  More Information

Additional Information:
Responsible Party: Alicia Aleman, Clinical and Epidemiological Research Unit Montevideo
ClinicalTrials.gov Identifier: NCT00781066     History of Changes
Other Study ID Numbers: CCT 06-00051
D43TW005492 (NIH grant number)
D43TW005492 ( U.S. NIH Grant/Contract )
First Submitted: October 27, 2008
First Posted: October 28, 2008
Last Update Posted: October 28, 2008
Last Verified: October 2008

Keywords provided by Universidad de la Republica:
POSTPARTUM HEMORRHAGE
PREVENTION
CORD TRACTION
THIRD STAGE LABOR

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage