Management of the Third Stage of Labor
Primary Purpose
Postpartum Hemorrhage
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Oxytocin
Oxytocin in 100 ml NaCl 0.9%
Sponsored by
About this trial
This is an interventional treatment trial for Postpartum Hemorrhage
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Intramuscular treatment:IV
Combined treatment:IV+IM
The control group
Arm Description
pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.
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.
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).
Outcomes
Primary Outcome Measures
Change in Hemoglobin concentration during labor
Secondary Outcome Measures
Blood count (CBC) on the first and second day after delivery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02319707
Brief Title
Management of the Third Stage of Labor
Official Title
Management of the Third Stage of Labor
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yariv yogev
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intramuscular treatment:IV
Arm Type
Experimental
Arm Description
pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.
Arm Title
Combined treatment:IV+IM
Arm Type
Experimental
Arm Description
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.
Arm Title
The control group
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Pitocin
Intervention Description
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
Intervention Name(s)
Oxytocin in 100 ml NaCl 0.9%
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change in Hemoglobin concentration during labor
Time Frame
first and second day after delivery
Secondary Outcome Measure Information:
Title
Blood count (CBC) on the first and second day after delivery
Time Frame
first and second day after delivery
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yariv Yogev, professor
Phone
9723-9377490
Email
yarivy@clalit.org.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yariv Yogev, professor
Organizational Affiliation
Director, Division of obstetrics and delivery
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
33169839
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.
Results Reference
derived
Learn more about this trial
Management of the Third Stage of Labor
We'll reach out to this number within 24 hrs