Different Methods of Termination of Second Trimester Abortion
NCT ID: NCT03400683
Last Updated: 2018-01-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
150 participants
INTERVENTIONAL
2018-01-31
2018-07-31
Brief Summary
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Detailed Description
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Group 'A" (misoprostol only group): Pharmacological method for termination of second trimester missed abortion was done by given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses.
Group 'B'(misoprostol with letrozole group): The anti-estrogen action of letrozole has been show to be useful in pretreatment for termination of pregnancy ,in combination with misoprostol,women in the letrozole group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.
Group 'C' (misoprotol with Foley's catheter group): Mechanical method for termination of second trimester missed abortion was done using the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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misoprostol only group
given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses
Misoprostol
200 microgram misoprostol in sublingual every four hours for a maximum of five doses
misoprostol with letrozole group
group received 15mg( letrozole2.5mg) on three successive day patient take doses of letrozole for daily oral three successive day at home by herself and forth day admitted to our hospital followed by sublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
Misoprostol
200 microgram misoprostol in sublingual every four hours for a maximum of five doses
Letrozole
15mg( letrozole 2.5mg) on three successive day
misoprotol with Foley's catheter group
the transcervical 16F Foley's catheter with 30 ml balloon capacity (Euromed for Medical Industries, Cairo, Egypt, under license of Kanglite, USA), inserted under aseptic conditions withsublingual misoprostol 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), every four hours for a maximum of five doses
Misoprostol
200 microgram misoprostol in sublingual every four hours for a maximum of five doses
Foley's catheter
transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions
Interventions
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Misoprostol
200 microgram misoprostol in sublingual every four hours for a maximum of five doses
Letrozole
15mg( letrozole 2.5mg) on three successive day
Foley's catheter
transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* gestational age between 14 and 24 weeks
* Fetal death was confirmed by ultrasonic scan
* Unfavorable cervix using Bishop score for cervical assessment with score less than 5
* Parity less than 5
* No uterine contractions
Exclusion Criteria
* Rupture of membranes
* Chorioamnionitis
* Placenta previa or low lying placenta.
* Women with medical disease like DM, coagulopathy or genital infections.
* Hypersensitivity or contraindications for receiving misoprostol, including:Maternal asthma.Sickle cell disease.Known hypersensitivity to prostaglandins.History of glaucoma
18 Years
40 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Ahmed Maged
professor
Principal Investigators
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Ahmed Maged
Role: PRINCIPAL_INVESTIGATOR
Professor
Locations
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Kasr Alainy medical school
Cairo, , Egypt
Countries
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Central Contacts
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Other Identifiers
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18
Identifier Type: -
Identifier Source: org_study_id
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