Controlled Cord Traction During Third Stage of Labor - Full Text View

Sponsors and Collaborators:	Universidad de la Republica Clinical and Epidemiological Research Unit Montevideo Institute for Clinical Effectiveness and Health Policy
Information provided by:	Universidad de la Republica
ClinicalTrials.gov Identifier:	NCT00781066

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:

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.

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

MedlinePlus related topics: Postpartum Care

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Controlled Cord Traction During Third Stage of Labor: Pilot Trial

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Manual removal of placenta [ Time Frame: within 1 hour after delivery ] [ Designated as safety issue: Yes ]
Uterine inversion [ Time Frame: within 30 minutes after delivery ] [ Designated as safety issue: Yes ]
Uterine curettage [ Time Frame: before hospital discharge ] [ Designated as safety issue: Yes ]
Blood transfusion [ Time Frame: before Hospital discharge ] [ Designated as safety issue: No ]
Length of third stage of labor (minutes) [ Time Frame: until expulsion of the placenta ] [ Designated as safety issue: No ]

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
1: Experimental Controlled cord traction (CCT)	Procedure: Controlled cord traction 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.
2: Active Comparator No CCT	Procedure: No controlled cord traction 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.

Arms

Assigned Interventions

1: Experimental

Controlled cord traction (CCT)

Procedure: Controlled cord traction

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.

2: Active Comparator

No CCT

Procedure: No controlled cord traction

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.

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: 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

Clinical and Epidemiological Research Unit Montevideo

Institute for Clinical Effectiveness and Health Policy

Investigators

Principal Investigator:

Alicia V Aleman, MD

Clinical and Epidemiological Research Unit Montevideo

More Information

Additional Information:

School of Medicine of the University of the Republic This link exits the ClinicalTrials.gov site

Clinical and Epidemiological Research Unit Montevideo This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Clinical and Epidemiological Research Unit Montevideo ( Alicia Aleman )
Study ID Numbers:	CCT 06-00051, D43TW005492 (NIH grant number)
Study First Received:	October 27, 2008
Last Updated:	October 27, 2008
ClinicalTrials.gov Identifier:	NCT00781066 History of Changes
Health Authority:	Uruguay: Comite de Etica

Keywords provided by Universidad de la Republica:

POSTPARTUM HEMORRHAGE
PREVENTION
CORD TRACTION
THIRD STAGE LABOR

Study placed in the following topic categories:

Postpartum Hemorrhage
Pregnancy Complications
Uterine Hemorrhage

Puerperal Disorders
Obstetric Labor Complications
Hemorrhage

Additional relevant MeSH terms:

Postpartum Hemorrhage
Pregnancy Complications
Pathologic Processes
Uterine Hemorrhage

Puerperal Disorders
Obstetric Labor Complications
Hemorrhage

ClinicalTrials.gov processed this record on May 07, 2009