Clinical trial NCT01094028: Intraumbilical Vein Injection of Oxytocin in Routine Practice for Active Management of the Third Stage of Labor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Labor
Keywords: Blood loss in the third and fourth stage of labor and the duration of third stage of labor
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2010-03-26
Enrollment: 412
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* history of anticoagulant drugs
* beta-mimetic medications during pregnancy
* prolongation of the first stage of labor \> 15 hours.

Primary outcomes:
measure: the amount of blood loss in third and fourth stages of labor
timeFrame: The end of the delivery to 2 hours after birth.
Secondary outcomes:
measure: duration of the third stage
Other outcomes:
Locations:
Study officials:
References:
citation: 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.