Prophylactic Oxytocin Before Versus After Placental Delivery to Reduce Blood Loss in Vaginal Delivery

NCT ID: NCT03006380

Last Updated: 2017-03-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-09-30

Brief Summary

Randomized controlled study to assess the efficacy and safety of the timing of administration of prophylactic oxytocin via intramuscular route (before compared to after placental delivery) on blood loss in vaginal delivery.

Detailed Description

400 patients will be recruited for the study,Informed consent will be obtained from all patients following the research criteria once they are admitted in active labor, but they will be enrolled and randomized only when they reach the second stage of labor (fully dilated cervix) as it will be difficult in this stage to counsel patients.

The recruited patients will be subjected to the following:

• History taking: with particular emphasis on past medical history (especially for bleeding tendency), past obstetric history.
• Checking vital signs, General and abdominal examination.
• laboratory investigations: complete blood count (CBC)
• Findings of the initial obstetric evaluation follow up, labor duration and the need for oxytocin augmentation will be recorded through a partogram.
• All deliveries will be attended by a senior resident in the hospital.
• Included patients will receive the medication according to randomization tables.
• After allocation, patients will be excluded only if they required cesarean section, instrumental delivery or had multiple or deep vaginal tears that compromise estimation of uterine blood loss.
• All patients will undergo gentle traction to the umbilical cord while providing counter traction against the uterine fundus after signs of placental separation; appearance of bleeding, elongation of the cord.
• All patients will undergo cord clamping and cutting within 30 seconds of delivery.
• All patients will undergo uterine massage for 30 seconds after placental delivery.
• Vital signs (blood pressure and pulse) will be checked 15 minutes, 1 hour and 6 hours after placental delivery.
• CBC will be collected 6 hours after delivery.

Conditions

Postpartum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

oxytocin before placental delivery

patients who will receive 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly at delivery of anterior shoulder of the fetus and an identical placebo injection (normal saline, NACL 0.9%) intramuscularly following delivery of the placenta.

Group Type: EXPERIMENTAL

oxytocin

Intervention Type: DRUG

Ecbolic used to reduce blood loss

oxytocin after placental delivery

patients who will receive placebo injection (normal saline, NACL 0.9%) intramuscularly at delivery of anterior shoulder of the fetus and 10 IU of oxytocin (syntocinon®, NOVARTIS, Egypt) intramuscularly following delivery of the placenta.(opposite medication sequence)

Group Type: EXPERIMENTAL

oxytocin

Intervention Type: DRUG

Ecbolic used to reduce blood loss

Interventions

oxytocin

Ecbolic used to reduce blood loss

Intervention Type: DRUG

Other Intervention Names

Syntocinon®, NOVARTIS, Egypt

Eligibility Criteria

Inclusion Criteria

1. Multiparous women (had previous one, up to four deliveries)

2. Term pregnancy (37 completed weeks at least).

3. Singleton viable cephalic pregnancy.

4. Vaginal delivery.

Exclusion Criteria

1. Primigravida.(first pregnancy)

2. Grand multiparous. (had previous 5 or more deliveries)

3. Maternal illness (involving pregnancy induced condition; PIH,GDM or chronic medical condition; hypertension, cardiac , renal problems)

4. Previous cesarean section, uterine surgery.

5. Patients with bleeding tendency.

6. Previous history of Ante-partum hemorrhage.

7. Previous history of postpartum hemorrhage.

8. Abnormal site of the placenta (detected by ultrasound)

9. Macrosomic baby (EFW more than 4000 gm estimated clinically or by ultrasound)

10. polyhydramnios.(detected by ultrasound)

11. Multiple gestation.

12. Chorioamnionitis.

13. Suspected fetal problem(anomaly, distress)

14. Instrumental delivery.

15. Multiple or deep vaginal tears that compromise the estimation of uterine blood loss.

16. Cesarean delivery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams Maternity Hospital

OTHER

Sponsor Role: lead

Responsible Party

AMR HELMY YEHIA

Associate Professor of obstetrics and gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amr Yehia, MD, MRCOG

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Reham Marie, MRCOG

Role: CONTACT

rehamfarghal84@gmail.com

+201212977339

Facility Contacts

Amr Yehia, MD

Role: primary

Other Identifiers

oxytocin

Identifier Type: -

Identifier Source: org_study_id