Clinical trial NCT02319707: Management of the Third Stage of Labor
Official title: Management of the Third Stage of Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postpartum Hemorrhage
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
First posted: 2014-12-18
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the efficacy of three different protocols of third stage management in preventing PPH.

Detailed description: The third stage of labor refers to the period following the completed delivery of the newborn until the completed delivery of the placenta. The length of the third stage and its complications are affected by the uterine contractility and the duration of placental separation. The normal duration of third stage in nulliparous as well as in multiparous women is less than 30 minutes. There is strong evidence supporting the routine administration of uterotonic agents for the prevention of post-partum hemorrhage (PPH), in order to enhance natural uterine contraction in the third stage of labor, thus reducing the occurrence of PPH by 40%.

There is a joint policy statement between the International Confederation of Midwives (ICM), the International Federation of Gynecology and Obstetrics (FIGO) and the World Health Organization (WHO), all of which recommend active management of the third stage of labor in order to prevent PPH. active management led to a reduction in PPH incidence, maternal Hemoglobin\<9g/dL and need for blood transfusion. (4-7).

Active management of the third stage of labor involves prophylactic uterotonic treatment, early cord clamping and controlled cord traction to deliver the placenta. (2) Oxytocin is the first agent of choice for PPH prophylaxis because of its high efficacy and a low incidence of associated side effects. (6-9). Cotter et al found that the use of Oxytocin for PPH prophylaxis in the third stage of labor decreased the rate of maternal blood loss greater than 500 ml by approximately 50%. (10).

Oxytocin route of administration is either intravenously (IV) or intramuscularly (IM), with no significant difference in PPH incidence (9). This is based on a pharmacokinetic research from 1972 which found no difference between the absorption rates in both routes of administration. Since then no further research targeting this question was preformed. (11-12). recent guidelines from WHO, FIGO and ICM all recommended the use of 10 IU Oxytocin IM. (4, 7,13).

Previous studies have investigated the effect of intra-umbilical vein Oxytocin injection in reducing blood loss during the third stage of labor. This route of administration directs treatment to the placental bed and uterine wall, resulting in earlier uterine contraction and placental separation. However, limited published literature is available evaluating the effect of umbilical vein oxytocin injection in routine practices for active management of the third stage of labor. A prospective, randomized controlled trial of 412 women found that intra-umbilical injection of oxytocin alongside active management of the third stage of labor significantly reduced postpartum blood loss and the duration of the third stage (14).

Other uterotonic agents including Syntometrine (IM), Ergometrine (IM or IV) and Misoprostol (IM), can be used in active management of the third stage of labor. However, high quality evidence regarding their efficacy compared to Oxytocin is scarce. (9-10)

Eligibility criteria: Inclusion Criteria:

* Singleton pregnancy.
* 34-41 weeks of gestation.
* Maternal age between 18 and 45.

Exclusion Criteria:

* Women who enter delivery room during the active phase of labor (cervical dilatation greater than 5 cm)
* Coagulation defects
* VAS score\>3 (pain score)
* Women with early PPH
* Suspected placental abruption

Primary outcomes:
measure: Change in Hemoglobin concentration during labor
timeFrame: first and second day after delivery
Secondary outcomes:
measure: Blood count (CBC) on the first and second day after delivery
timeFrame: first and second day after delivery
Other outcomes:
Locations:
Study officials:
affiliation: Director, Division of obstetrics and delivery
name: Yariv Yogev, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Oladapo OT, Okusanya BO, Abalos E, Gallos ID, Papadopoulou A. Intravenous versus intramuscular prophylactic oxytocin for the third stage of labour. Cochrane Database Syst Rev. 2020 Nov 9;11(11):CD009332. doi: 10.1002/14651858.CD009332.pub4.