Induction of AbortionNCT03400683
Different Methods of Termination of Second Trimester Abortion
A study testing Misoprostol, Letrozole and Foley's catheter in people with Induction of Abortion, run by Cairo University at 1 site in Egypt.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Induction of Abortion
- What is being tested?
- Misoprostol, Letrozole and Foley's catheter
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2018to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
ameer elsherief contact
About this study
Official title: Different Methods of Termination of Second Trimester Abortion: Comparative Clinical Study
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
Read the 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.
- Conditions
- Induction of Abortion
- Being tested
- Misoprostol, Letrozole, Foley's catheter
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Misotac
200 microgram misoprostol in sublingual every four hours for a maximum of five doses
LetrozoleDrug
Also called Femara
15mg( letrozole 2.5mg) on three successive day
Foley's catheterProcedure or surgery
Also called Urinary catheter
transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions
| Study group | Role | What they receive |
|---|---|---|
| misoprostol only group | Active comparator | given 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses Receives: Drug: Misoprostol |
| misoprostol with letrozole group | Active comparator | 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 Receives: Drug: Misoprostol; Drug: Letrozole |
| misoprotol with Foley's catheter group | Active comparator | 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 Receives: Drug: Misoprostol; Procedure: Foley's catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete evacuation of uterus
clear endometrial line < 4 mm in thickness
Measured: 24 hours after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJun 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Induction of AbortionStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03400683
- Sponsor's protocol ID
- 18
- Status last verified
- Jan 2018
- First submitted
- 8 Jan 2018
- Last updated
- 25 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Methods of Termination of Second Trimester Abortion: Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT03400683
- Acronym / sponsor ID
- 18
- Conditions
- Induction of Abortion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 17 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| misoprostol only group | Active comparator | Drug: Misoprostolgiven 200 microgram misoprostol (Misotac 200 microgram tablet, Sigma Pharmaceuticals, Egypt), in sublingual every four hours for a maximum of five doses |
| misoprostol with letrozole group | Active comparator | Drug: Misoprostol, Drug: Letrozolegroup 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 |
| misoprotol with Foley's catheter group | Active comparator | Drug: Misoprostol, Procedure: Foley's catheterthe 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: Misotac200 microgram misoprostol in sublingual every four hours for a maximum of five doses | Drug | misoprostol only group, misoprostol with letrozole group, misoprotol with Foley's catheter group |
| LetrozoleAlso: Femara15mg( letrozole 2.5mg) on three successive day | Drug | misoprostol with letrozole group |
| Foley's catheterAlso: Urinary cathetertranscervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions | Procedure or surgery | misoprotol with Foley's catheter group |
Primary outcome
complete evacuation of uterus
Time frame: 24 hours after treatment
clear endometrial line < 4 mm in thickness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2018.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ameer elsherief contact
Ahmed Maged principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol, Letrozole and Foley's catheter in people with Induction of Abortion, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed maged (+20201005227404, dr_ahmedmaged08@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete evacuation of uterus (time frame: 24 hours after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2018; AzTrials last refreshed its copy on 1 Nov 2026.