Back to resultsVaginal Misoprostol In Management Of First Trimester Missed Abortion.
Primary Purpose
Abortion, Missed
Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
vaginal misoprostol
buccal/sublingual misoprostol
Sponsored by
About this trial
This is an interventional treatment trial for Abortion, Missed
Eligibility Criteria
Inclusion Criteria:
- single dead fetus up-to 12 weeks.
- no low lying placenta
- no scarred uterus
- no or mild bleeding
- no evidence of infection
- accepting to participate in the study.
Exclusion Criteria:
- Advanced hepatic diseases .
- Suspected molar pregnancy
- Ectopic pregnancy or pregnancy of unknown location
- Haemodynamically unstable with significant anaemia ie Hb<10
- Uncontrolled severe asthma
- Chronic adrenal failure
- Known or suspected heart disease
- Glaucoma
- Haemoglobinopathies
- Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
- Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
- Patient living in remote areas with difficulty in accessing hospital
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
hospital- based standard dose of vaginal misoprostol
Home-based extended low dose of buccal/sublingual misoprostol
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients with complete abortion (success rate).
Secondary Outcome Measures
Number of misoprostol doses
induction-abortion time
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03148314
Brief Title
Vaginal Misoprostol In Management Of First Trimester Missed Abortion.
Official Title
Home-Based Extended Low Dose Buccal Misoprostol Versus Hospital-Based Standard Vaginal Dose In Management Of First Trimester Missed Abortion.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Unknown status
Study Start Date
June 2017 (Anticipated)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
July 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The world health organization defined abortion or miscarriage as : the expulsion or extraction from its mother of a fetus or an embryo weighting 500 grams or less ,or any other wise product of gestation of any weight irrespective of gestational age and weather or not there is evidence of life and weather or not the abortion was spontaneous or induced Miscarriage is the most common complication of pregnancy occurring in 10-20% of clinically recognized pregnancies (Bag. It is estimated that around 40% of early pregnancies result in miscarriage. A large majority of those are lost before the menstrual period is missed. More than 80%of abortions occur in first 12 weeks of pregnancy, and the rate decrease there after For clinical purposes: abortion is subdivided into: threatened abortion, inevitable abortion, incomplete abortion ,missed abortion ,septic abortion ,and recurrent abortion
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abortion, Missed
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hospital- based standard dose of vaginal misoprostol
Arm Type
Other
Arm Title
Home-based extended low dose of buccal/sublingual misoprostol
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
vaginal misoprostol
Intervention Description
(800µgm.x 2 doses 3 hours).
Intervention Type
Drug
Intervention Name(s)
buccal/sublingual misoprostol
Intervention Description
200 µgm.x4 hrs.x 6 doses
Primary Outcome Measure Information:
Title
Percentage of patients with complete abortion (success rate).
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Number of misoprostol doses
Time Frame
1 week
Title
induction-abortion time
Time Frame
1 week
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
single dead fetus up-to 12 weeks.
no low lying placenta
no scarred uterus
no or mild bleeding
no evidence of infection
accepting to participate in the study.
Exclusion Criteria:
Advanced hepatic diseases .
Suspected molar pregnancy
Ectopic pregnancy or pregnancy of unknown location
Haemodynamically unstable with significant anaemia ie Hb<10
Uncontrolled severe asthma
Chronic adrenal failure
Known or suspected heart disease
Glaucoma
Haemoglobinopathies
Haemorrhagic disorders and anti-coagulation therapy (aspirin accepted)
Adrenal suppression and long term glucocorticoid therapy (may require corticosteroid)
Patient living in remote areas with difficulty in accessing hospital
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34061352
Citation
Ghosh J, Papadopoulou A, Devall AJ, Jeffery HC, Beeson LE, Do V, Price MJ, Tobias A, Tuncalp O, Lavelanet A, Gulmezoglu AM, Coomarasamy A, Gallos ID. Methods for managing miscarriage: a network meta-analysis. Cochrane Database Syst Rev. 2021 Jun 1;6(6):CD012602. doi: 10.1002/14651858.CD012602.pub2.
Results Reference
derived
Learn more about this trial
Vaginal Misoprostol In Management Of First Trimester Missed Abortion.
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