Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704780
Other study ID # HawlerMU
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2016
Est. completion date February 14, 2019

Study information

Verified date February 2019
Source Hawler Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 509
Est. completion date February 14, 2019
Est. primary completion date February 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years to 45 Years
Eligibility 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

Study Design


Intervention

Drug:
Misoprostol
2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women

Locations

Country Name City State
Iraq Hawler Medical university Erbil Kurdistan Region

Sponsors (1)

Lead Sponsor Collaborator
Hawler Medical University

Country where clinical trial is conducted

Iraq, 

Outcome

Type Measure Description Time frame Safety issue
Primary Delivery of placenta after injection of of 400 Microgram intraumbilical misoprostol versus 800 microgram of misoprostol complete delivery of placenta after injection of intraumbilical misoprostol up to 30 minutes after intraumbilical injection
Secondary The amount of blood loss vaginally in both groups To estimate the amount of vaginal blood loss from time of injection of the the interventional drug and till the delivery of the placenta up to 30 minutes after injection of placenta
Secondary The time of delivery of placenta in both groups the time interval estimation from the injection to complete delivery of the placenta up to 30 minutes after delivery of the placenta
Secondary side effects of misoprostol Any side effects related to misoprostol after the injection (Fever, severing , diarrhea) up to 24 hours after delivery of placenta
See also
  Status Clinical Trial Phase
Completed NCT02509351 - Could Pre-operative Rectal Misoprostol Reduce Intra-operative Blood Loss During Ceserean Section? Phase 2/Phase 3
Completed NCT01931423 - The Influence of Placental Drainage of Management of the Third Stage of Labor:a Randomized Controlled Study N/A
Completed NCT00499005 - Carbetocin Versus Syntometrine for the Third Stage of Labour Phase 4
Completed NCT01485562 - Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births N/A
Completed NCT01359878 - Fibrinogen Concentrate as Initial Treatment for Postpartum Haemorrhage: A Randomised Clinically Controlled Trial Phase 2/Phase 3
Completed NCT00872469 - World Maternal Antifibrinolytic Trial Phase 3
Not yet recruiting NCT02396303 - Carbetocin Versus Oxytocin in Caesarean Section for the Control of Postpartum Haemorrhage Phase 0
Completed NCT01895218 - Treatment of Women After Postpartum Haemorrhage Phase 3
Completed NCT01931410 - The Effect of Rectal and Sublingual Misoprostol Administration in Postpartum or Intrapartum Haemorrhage at Elective Caesarean Delivery: a Randomized Controlled Trial Phase 4
Recruiting NCT02187874 - Timing of Umbilical Cord Occlusion in Premature Babies( <33 w). Delayed vs Early. N/A
Withdrawn NCT01910675 - PCC and Fibrinogen Compared With FFP in PPH Phase 4
Completed NCT02562300 - Uterotonics Using to Reduce Bleeding at Cesarean Section Phase 2
Completed NCT01044082 - Prevention of Post-partum Haemorrhage N/A
Completed NCT01116050 - Intrarectal Misoprostol in Postpartum Haemorrhage Phase 3
Completed NCT02149472 - Towards Better Prognostic and Diagnostic Strategies for Haemostatic Changes During Major Obstetric Haemorrhage
Recruiting NCT02492087 - Topical Tranexamic Acid in Caesarean Section Phase 3
Completed NCT02468310 - Evaluating the Effects of SMS Text Messaging Support System Among Frontline Health Workers in Ghana N/A
Recruiting NCT02136719 - Bimanual Uterine Compression to Reduce Blood Loss and Prevent Postpartum Haemorrhage After Vaginal Delivery N/A