Controlled Cord Traction During Third Stage of Labor

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. 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.

Conditions

• Postpartum Hemorrhage

Interventions

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.

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.

Sponsors & Collaborators

• Unidad de Investigación Clínica y Epidemiológica Montevideo

  collaborator OTHER

• Institute for Clinical Effectiveness and Health Policy

  collaborator OTHER

• Universidad de la Republica

  lead OTHER

Principal Investigators

• Alicia V Aleman, MD · Unidad de Investigación Clínica y Epidemiológica Montevideo

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2007-01-31

Primary Completion

2007-09-30

Completion

2007-09-30

Countries

• Uruguay

Study Locations