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Misoprostol Versus Active Management of Labour in CS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03390010
Recruitment Status : Completed
First Posted : January 4, 2018
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Aljazeera Hospital

Study Description
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Brief Summary:
Several treatment strategies are emplemented to prevent post delivery hemorage and decreasing maternal morbidity and mortality .

Condition or disease Intervention/treatment Phase
Cesarean Section Drug: Misoprostol + syntocinon and methergine drugs Drug: Syntocinon plus methergine drugs Phase 1

Detailed Description:

Many approved drugs are used in prophylaxis against postpartum hemorage from these medications are the (syntocinon combined with methergine ) that are known as active management of labour drugs .

Moreover there is misotac , that also guards against postpartum hemorage .

All these medications act in a different way to cause uterine contraction post delivery to prevent uterine atony .

-Here we are comparing the additive value of misotac intrauterine to syntocinon and methergine in comparison to the usually used syntocinon plus methergine .

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Intrauterine Misoprostol With Active Management of Labour Versus Active Management of Labour for Prevebtion of Postpartum Hemorage in Cesarean Section ,Randomized Controlled Trial
Actual Study Start Date : December 28, 2017
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : June 6, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Extra medication group

-Procedure : Giving misoprostol plus syntocinon and methergibe drugs during CS

this group in which prevention of uterine atony is made by intrauterine misotac plus the usual syntocinon and methergine during cesarean section

 Drug: Misoprostol + syntocinon and methergine drugs
medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and methergine
Other Name: DrugsMisoprostol plus syntocinon and metehrgine

Drug: Syntocinon plus methergine drugs
medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and methergine
Other Name: drugs ( syntocinon and methergine )
Active Comparator: Active management of labour group
  • Procedure: Giving syntocinon and methergine drugs during cesarean section
  • this group in which prevention of uterine atony is made by the usual active management of labour syntocinon and methergine during cesarean section
 Drug: Misoprostol + syntocinon and methergine drugs
medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and methergine
Other Name: DrugsMisoprostol plus syntocinon and metehrgine

Drug: Syntocinon plus methergine drugs
medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and methergine
Other Name: drugs ( syntocinon and methergine )


Outcome Measures
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Primary Outcome Measures :
  1. The number of participants who passed cesarean section without postpartum hemorage [ Time Frame: within 2 days post CS ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   pregnant females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • • All patients included in this research were aged 18-42 years, BMI 20-30,

    • no medical disorders with pregnancy e.g DM, HTN. All patients were subjected to full history taking, examination.

Exclusion Criteria:

  • Exclusion Criteria:

    • The following patients were excluded ,medical disorders with pregnancy eg. DM with pregnancy, HTN with pregnancy
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03390010


Locations
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Egypt
Algazeerah
Giza, Egypt
Sponsors and Collaborators
Aljazeera Hospital
Cairo University
Investigators
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Study Chair: Mahmoud Alalfy, M.s.c Algazeerah hospital -Location (Giza -Egypt )
Principal Investigator: yossra Lasheen, M.D kasraliny hospital- Aljazeerah hospital
More Information
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Responsible Party: Aljazeera Hospital
ClinicalTrials.gov Identifier: NCT03390010    
Other Study ID Numbers: Active management of labour
First Posted: January 4, 2018    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Misoprostol
Oxytocin
Methylergonovine
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics