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Two Different Regimens of Misoprostol in Retained Placenta

H

Hawler Medical University

Status and phase

Completed
Phase 2

Conditions

Postpartum Haemorrhage
Retained Placenta

Treatments

Drug: Misoprostol

Study type

Interventional

Funder types

Other

Identifiers

NCT02704780
HawlerMU

Details and patient eligibility

About

This study evaluates intra umbilical vein injection of 800 µg versus 400 µg misoprostol for the treatment of retained placenta to reduce the need of manual removal of placenta under general anaesthesia

Full description

The third stage of labor may be complicated by retained placenta, which may cause severe bleeding and infection, with a potentially fatal outcome. Manual removal of placenta is the current standard of management of retained placenta which usually requires general or regional anaesthesia at a hospital and it is an invasive procedure that may lead to bleeding, trauma and infection. Intraumbilical injection of uterotonic agent( misoprostol) is an easy, non invasive procedure. A randomized clinical trial are required to determine the difference between two doses of misoprostol 400 versus 800 micro gram for management of retained placenta

Enrollment

509 patients

Sex

Female

Ages

15 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • women with a singleton pregnancy, delivered vaginally
  • 28 weeks of gestation and more,
  • had a prolonged third stage of labor (more than 30 minutes) despite active management,
  • Haemodynamically stable and accept to participate in the trial

Exclusion criteria

  • multiple pregnancies,
  • previous caesarean delivery,
  • haemodynamically instability, severe anaemia (haemoglobin concentration <8 g/dL),
  • chorioamnionitis
  • Refused to participate in the trial

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

509 participants in 2 patient groups

400 Microgram Misoprostol
Active Comparator group
Description:
Misoprostol 400 micro-gram dissolved in 20 mL normal saline will be injected in the umbilical vein in the first group
Treatment:
Drug: Misoprostol
800 Microgram Misoprostol
Active Comparator group
Description:
Misoprostol 800 micro-gram dissolved in 20 mL normal saline will be injected in umbilical cord of the second group
Treatment:
Drug: Misoprostol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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