Clinical trial NCT02704780: Two Different Regimens of Misoprostol in Retained Placenta
Official title: Umbilical Vein Injection of 800µg Misoprostol Versus 400 µg Misoprostol in the Treatment of Retained Placenta: A Multicenter, Randomized Double Blind Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postpartum Haemorrhage
Retained Placenta
Keywords: Retained placenta
Misoprostol
double blind
Randomization
Haemorrhage
Lead sponsor: Hawler Medical University
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 509
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol
timeFrame: up to 30 minutes after intraumbilical injection
Secondary outcomes:
measure: The amount of blood loss vaginally in both groups
timeFrame: up to 30 minutes after injection of placenta
measure: The time of delivery of placenta in both groups
timeFrame: up to 30 minutes after delivery of the placenta
measure: side effects of misoprostol
timeFrame: up to 24 hours after delivery of placenta
Other outcomes:
Locations:
city: Erbil
country: Iraq
facility: Hawler Medical university
state: Kurdistan Region
Study officials:
affiliation: Hawler Medical University
name: Shahla K. Alalaf, professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hawler Medical University
name: Namir G. Al Tawil, Professor
role: STUDY_DIRECTOR
affiliation: KBMS
name: Ariana Kh. Jawad, Assistant professor
role: STUDY_CHAIR
affiliation: Maternity Teaching Hospital
name: Bahar Q. Muhammad, CABOG
role: STUDY_CHAIR
affiliation: Duhok university
name: Jinan N. Hassan, IBMS
role: STUDY_CHAIR
affiliation: Al-Azhar University
name: Salim A. Salim, Master
role: STUDY_CHAIR
affiliation: Karkuk Medical college
name: Khalida M. Ameen, CABOG
role: STUDY_CHAIR
affiliation: Sulaimani Maternity Hospital
name: Maryam B. Mahmood, FICOG
role: STUDY_CHAIR
affiliation: Maternity Teaching Hospital
name: Khansa H. Abdul Rahman, MBChB
role: STUDY_CHAIR
References:
citation: Kumar N, Jahanfar S, Haas DM, Weeks AD. Umbilical vein injection for management of retained placenta. Cochrane Database Syst Rev. 2021 Mar 11;3(3):CD001337. doi: 10.1002/14651858.CD001337.pub3.