Clinical trial NCT03400683: Different Methods of Termination of Second Trimester Abortion
Official title: Different Methods of Termination of Second Trimester Abortion: Comparative Clinical Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Induction of Abortion
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Patient are divided into 3 groups group 1 included 50 cases using misoprostol only. group 2 included also 50 cases in which using misoprostol with letrozole. Group3 included also 50 cases in which using misoprostol with Foleys catheter for termination of second trimesteric abortion between 14 and 24 weeks

Detailed description: Pregnant women were randomized into three equal groups: Group allocation was blindly randomized concealed by placement in numbered opaque sealed envelopes. These envelopes were kept in the labor ward and drawn in consecutive order:

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.

Eligibility criteria: Inclusion Criteria:

* singleton pregnancy
* 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:

* Previous uterine scar eg scar for cessarian section
* 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

Primary outcomes:
measure: complete evacuation of uterus
timeFrame: 24 hours after treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Kasr Alainy medical school
Study officials:
affiliation: Professor
name: Ahmed Maged
role: PRINCIPAL_INVESTIGATOR
References: