Management of the Third Stage of Labor

NCT ID: NCT02319707

Last Updated: 2015-09-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2017-01-31

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)

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intramuscular treatment:IV

pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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.

Combined treatment:IV+IM

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.

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

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.

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).

Group Type: ACTIVE_COMPARATOR

Oxytocin in 100 ml NaCl 0.9%

Intervention Type: DRUG

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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Pitocin

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yariv yogev

OTHER

Sponsor Role: lead

Responsible Party

Yariv yogev

Prof. Yariv Yogev Director, Division of obstetrics and delivery

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yariv Yogev, professor

Role: PRINCIPAL_INVESTIGATOR

Director, Division of obstetrics and delivery

Central Contacts

Yariv Yogev, professor

Role: CONTACT

yarivy@clalit.org.il

9723-9377490

References

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.

Reference Type: DERIVED

PMID: 33169839 (View on PubMed)

Other Identifiers

0553-14-RMC

Identifier Type: -

Identifier Source: org_study_id