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Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage

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ClinicalTrials.gov Identifier: NCT02686840
Recruitment Status : Completed
First Posted : February 22, 2016
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdel Shafy El Shahawy, Ain Shams University

Study Description
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Brief Summary:
The aim of this work is to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.

Condition or disease Intervention/treatment Phase
Missed Abortion Drug: sublingual misoprostol Drug: vaginal misoprostol Phase 3

Detailed Description:
In women with first trimetric-missed miscarriage, sublingual misoprostol may be as vaginal misoprostol in achievement of successful miscarriage so our aim was to compare the effectiveness of vaginal versus sub-lingual misoprostol for medical treatment of first trimester missed miscarriage.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sublingual Versus Vaginal Misoprostol In Medical Treatment of First Trimestric Missed Miscarriage: A Randomized Controlled Trial.
Actual Study Start Date : January 2016
Actual Primary Completion Date : January 2017
Actual Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Miscarriage
Drug Information available for: Misoprostol

Arms and Interventions
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Arm Intervention/treatment
Experimental: sublingual misoprostol
Group A (100 patients): will be treated with sublingual misoprostol
 Drug: sublingual misoprostol

All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

  • Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
  • Paracetamol, eight hourly, will be provided as analgesic or antipyretic.
  • A specimen bottle to collect the POC if passed out.
  • Two pairs of disposable gloves.
  • Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception
Other Name: Misotac
Active Comparator: vaginal misoprostol
Group B (100 patients): will be treated with vaginal misoprostol
 Drug: vaginal misoprostol

All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.

Paracetamol, eight hourly, will be provided as analgesic or antipyretic

Other Name: Misotac


Outcome Measures
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Primary Outcome Measures :
  1. Completeness of abortion: expulsion of Products of conception (POC)x by visual inspection [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Successful medical abortion: cervical os is closed with endometrial thickness of less than 15 mm [ Time Frame: 7 days ]
  2. Failure: endometrial thickness of more than 15 mm on day seven (from third dose of misoprostol) or developing of complications before day seven needing early surgical evacuation. [ Time Frame: 7 days ]
  3. Bleeding pattern following treatment [ Time Frame: 7 days ]
    This will be assessed by hemoglobin(g/dl) and haematocrit level after the treatment , if the patients required blood transfusion and number of units transfused and number of days of bleeding

  4. Pain resulting from the procedure [ Time Frame: 7 days ]
    this will be assessed by the doses of paracetamol given in mg

  5. Additional uterotonic used [ Time Frame: 7 days ]
    additional misoprostol doses in mcg


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All women above 18 years of age
  • Less than 12 weeks of gestation.
  • Pregnancy is confirmed by pregnancy test or ultrasound scan.
  • missed abortion
  • Normal general and gynecological examination.
  • The size of the uterus on pelvic examination was compatible with the estimated duration of pregnancy

Exclusion Criteria:

  • Hemodynamically unstable.
  • Suspected sepsis with temperature 38 °C.
  • Concurrent medical illness e.g. hematological, cardiovascular, thromboembolism, respiratory illnesses, recent liver disease or pruritus of pregnancy.
  • Presence of intrauterine contraceptive device (IUCD).
  • Suspect or proven ectopic pregnancy.
  • Failed medical or surgical evacuation before presentation.
  • Known allergy to misoprostol.
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): NCT02686840


Locations
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Egypt
Ain shams university maternity hospital
Cairo, Egypt, 25187
Sponsors and Collaborators
Ain Shams University
Investigators
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Study Chair: Hassan A Bayoumy, MD Ain Shams University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ahmed Abdel Shafy El Shahawy, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT02686840    
Other Study ID Numbers: ASUMH
First Posted: February 22, 2016    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Abortion, Spontaneous
Abortion, Missed
Pregnancy Complications
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
 Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics