Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor

NCT01094028 | Completed Phase 3 DMC

• 1 other identifier: 07
• Study Type: interventional
• Target: 412
• Locations: 0 countries
• Sites: N/A

Brief Summary

During the first hours that follow the birth of the baby (third and fourth stages of labor), complications are common and can threaten the mother's life. The most common complication is postpartum hemorrhage (PPH), which remains a leading cause of maternal mortality (25.0%) especially in developing countries .Three to five percent of deliveries are complicated by PPH and is 50 times more common in developing countries. Retained placenta is an another complication of third stage of labor. It complicates 0.1-2 % of deliveries . Without prompt treatment, women are at high risk of hemorrhage. At present, treatment is by manual removal of placenta, which needs an operating theatre, a surgeon, and an anaesthetist-facilities that are often unavailable to women in resource-poor settings. As a result, this condition has a case fatality rate of nearly 10% in rural communities. The length of the third stage of labor, and its subsequent complications depends on a combination of the length of time it takes for placental separation and the ability of the uterine muscle to contract. Principal management of the third stage of labor is aimed at reducing the time of delivery of placenta so minimising serious adverse effects, such as blood loss and retained placenta. Active management of the third stage of labor, which includes prophylactic injection of 10 units of oxytocin within two minutes of birth, early clamping of the umbilical cord and controlled cord traction (CCT), is recommended by WHO for PPH prevention . Umbilical vein oxytocin injection directs the treatment to the placental bed and uterine wall, resulting in an earlier uterine contraction and placental separation. However, very limited published literature is available, which evaluated the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. The purpose of this investigation was to find out the beneficial effect of adding intraumbilical vein oxytocin in reducing the blood loss during third and fourth stages of labor, length of third stage of labor, and reduction in the incidence of manual removal of retained placenta.

Conditions

Labor

Keywords

Blood loss in the third and fourth stage of labor and the duration of third stage of labor

Outcome Measures

Primary Outcomes (1)

• the amount of blood loss in third and fourth stages of labor

  The end of the delivery to 2 hours after birth.

Secondary Outcomes (1)

• duration of the third stage

Study Arms (1)

Saline group

EXPERIMENTAL

Only 30 mL of saline was injected directly in the umbilical vein after clamping. The injection was performed with a 30-mL syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute and at the end of the injection, the solution was milked toward the cord insertion.

Drug: Oxytocin

Interventions

Oxytocin DRUG

20 IU of oxytocin diluted with 26 ml of saline.The medication was injected directly in the umbilical vein after clamping. The injection was performed with a 30-ml syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute, and at the end of the injection, the solution was milked toward the cord insertion

Saline group

Eligibility Criteria

• Age: 15 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• gestational age between 37 and 42 weeks
• singleton pregnancy
• live fetus
• cephalic presentation
• neonatal birth weight of 2500-4500 g
• parity between one and five
• maternal age \< 35 years
• vaginal birth

You may not qualify if:

• blood pressure ≥ 140/90mmHg
• placenta previa
• placental abruption
• a history of any bleeding during pregnancy
• a history of curettage
• cesarean section or any uterine scar
• a history of postpartum hemorrhage
• polyhydramnios
• signs or symptoms of maternal infection
• known uterine anomalies
• history of any drug use during labor
• abnormal placentation)
• coagulation defects
• instrumental deliveries
• hemoglobin concentration \< 8 g/dL

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Related Publications (1)

• Gungorduk K, Asicioglu O, Besimoglu B, Gungorduk OC, Yildirm G, Ark C, Tekirdag AI. Using intraumbilical vein injection of oxytocin in routine practice with active management of the third stage of labor: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):619-624. doi: 10.1097/AOG.0b013e3181edac6b.

  PMID: 20733444 DERIVED

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 22, 2010
• First Posted: March 26, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: March 26, 2010

Record last verified: 2009-12