Management of the Third Stage of Labor

Postpartum Hemorrhage Clinical Trial

Official title:

Management of the Third Stage of Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02319707
• Other study ID #: 0553-14-RMC
• Status: Not yet recruiting
• Phase: Phase 3
• First received: December 14, 2014
• Last updated: September 7, 2015
• Start date: September 2015
• Est. completion date: January 2017

Study information

• Verified date: September 2015
• Source: Rabin Medical Center
• Contact: Yariv Yogev, professor
• Phone: 9723-9377490
• Email: yarivy[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
The study group: divided into two groups: • Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor. • Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor.
• Oxytocin in 100 ml NaCl 0.9%
The control group: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yariv yogev

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin concentration during labor		first and second day after delivery	No
Secondary	Blood count (CBC) on the first and second day after delivery		first and second day after delivery	No