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Different Methods of Termination of Second Trimester Abortion

Different Methods of Termination of Second Trimester Abortion: Comparative Clinical Study

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03400683
Enrollment
150
Registered
2018-01-17
Start date
2018-01-31
Completion date
2018-07-31
Last updated
2018-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Abortion

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.

Interventions

DRUGMisoprostol

200 microgram misoprostol in sublingual every four hours for a maximum of five doses

DRUGLetrozole

15mg( letrozole 2.5mg) on three successive day

transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
complete evacuation of uterus24 hours after treatmentclear endometrial line \< 4 mm in thickness

Countries

Egypt

Contacts

Primary ContactAhmed maged
dr_ahmedmaged08@kasralainy.edu.eg+20201005227404
Backup Contactameer elsherief
ameerelsherief@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026