Controlled Cord Traction During Third Stage of Labor

NCT00781066 | Completed Phase 3 DMC

• 3 other identifiers: CCT 06-00051D43TW005492 (NIH grant number)D43TW005492
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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. 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. 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)?

Conditions

Postpartum Hemorrhage

Keywords

POSTPARTUM HEMORRHAGE; PREVENTION; CORD TRACTION; THIRD STAGE LABOR

Outcome Measures

Primary Outcomes (1)

• Postpartum blood loss

  a minimum of 20 minutes after delivery

Secondary Outcomes (5)

• Manual removal of placenta

  within 1 hour after delivery

• Uterine inversion

  within 30 minutes after delivery

• Uterine curettage

  before hospital discharge

• Blood transfusion

  before Hospital discharge

• Length of third stage of labor (minutes)

  until expulsion of the placenta

Study Arms (2)

1

EXPERIMENTAL

Controlled cord traction (CCT)

Procedure: Controlled cord traction

2

ACTIVE COMPARATOR

No CCT

Procedure: No controlled cord traction

Interventions

Controlled cord traction PROCEDURE

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

No controlled cord traction PROCEDURE

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.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Imminent vaginal delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de la Republica: lead
• Unidad de Investigación Clínica y Epidemiológica Montevideo: collaborator
• Institute for Clinical Effectiveness and Health Policy: collaborator

Study Sites (2)

Clinica's Hospital Manuel Quintela of the University of the Republic of Uruguay

Montevideo, Montevideo Department, 11600, Uruguay

Location

Pereira Rossell Hospital

Montevideo, Montevideo Department, 11600, Uruguay

Location

Related Publications (2)

• 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.

  PMID: 30514326 DERIVED

• Piaggio 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.

  PMID: 29945633 DERIVED

Related Links

• School of Medicine of the University of the Republic
• Clinical and Epidemiological Research Unit Montevideo

MeSH Terms

Conditions

Postpartum Hemorrhage

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Alicia V Aleman, MD

  Unidad de Investigación Clínica y Epidemiológica Montevideo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 27, 2008
• First Posted: October 28, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: October 28, 2008

Record last verified: 2008-10

Locations

UR (2)