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Intraumbilical Misoprostol in Retained Placenta

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistant Prof. Shahla Alalaf, Hawler Medical University
ClinicalTrials.gov Identifier:
NCT01840813
First received: April 18, 2013
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

Administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta and the amount of blood loss vaginally.


Condition Intervention Phase
Retained Placenta
Drug: Misoprostol
Drug: Normal saline
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Intra-umbilical Injection of Misoprostol Versus Normal Saline in the Management of Retained Placenta: Intrapartum Placebo-controlled Trial

Resource links provided by NLM:


Further study details as provided by Hawler Medical University:

Primary Outcome Measures:
  • delivery of placenta by medical intervention [ Time Frame: 30 minutes after the injection of misoprostol or normal saline in the umbilical vein ] [ Designated as safety issue: Yes ]
    The administration of intraumbilical misoprostol to women with retained placenta despite active management of third stage of labour reduces the need for manual removal of placenta under general anaesthesia.


Secondary Outcome Measures:
  • vaginal bleeding after misoprostol use [ Time Frame: 30 minutes after umbilical vein injection of misoprostol ] [ Designated as safety issue: Yes ]
    using intraumbilical misoprostol in women with retained placenta reduces the amount of blood loss vaginally.


Other Outcome Measures:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolabrity [ Time Frame: 2 hours after umbilical vein injection of misoprostol ] [ Designated as safety issue: Yes ]
    Local applications of misoprostol through umbilical vein is associated with less side effects like shivering, fever, dizziness vomiting, flushes, nausea, abdominal pain and headache


Enrollment: 46
Study Start Date: April 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol
4 misoprostol tablets (Misotac® 200 micrograms tablet) dissolved in 20 ml of normal saline injected to umbilical vein
Drug: Misoprostol
It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
Other Name: (Misotac)® tablet
Placebo Comparator: Normal saline
Normal saline 0.9%, 20 ml was injected in the umbilical vein in cases of retained placenta
Drug: Normal saline
It is a placebo group
Other Name: Normal saline 0.9%

Detailed Description:

Retained placenta (RP)is one of the complications of third stage of labour; it should be managed promptly as it may cause severe bleeding, infection, maternal morbidity and mortality .The current standard management of RP word wide, by manual removal aims to prevent these problems, but it is unsatisfactory method because it requires general anaesthesia in hospital, It is an invasive procedure with its own serious complications of bleeding, infection and genital tract injury. Umbilical vein injection of misoprostol is a simple, safe method and could be performed at the place of delivery .

  Eligibility

Ages Eligible for Study:   15 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • women having singleton pregnancy
  • 28 weeks of gestation or more delivered vaginally
  • prolongation of the third stage of labour (more than 30 min) following active management of third stage of labour

Exclusion Criteria:

  • Who refused to participate in the trial
  • Multiple pregnancies
  • Previous Caesarean Section
  • Haemodynamically unstable
  • Severe anaemia (haemoglobin less than 8gm/dl)
  • Chorioamnionitis
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01840813

Locations
Iraq
Maternity Teaching Hospital
Erbil city, Kurdistan region, Iraq, 383-65
Sponsors and Collaborators
Hawler Medical University
Investigators
Principal Investigator: Shahla K. Alalaf, Clinical M.D Hawler Medical University
Study Chair: Sheelan S Rajab, High Diploma , Shaheed Dr.Khalid General Hospital, Directorate of Health
  More Information

No publications provided

Responsible Party: Assistant Prof. Shahla Alalaf, Assistant Professor, Hawler Medical University
ClinicalTrials.gov Identifier: NCT01840813     History of Changes
Other Study ID Numbers: HMU911
Study First Received: April 18, 2013
Last Updated: November 1, 2013
Health Authority: Iraq: Ethics Committee

Keywords provided by Hawler Medical University:
Intraumbilical misoprostol
Retained placenta
Active management of third stage of labour

Additional relevant MeSH terms:
Placenta, Retained
Placenta Diseases
Pregnancy Complications
Misoprostol
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014