Second Trimester AbortionPhase 4NCT03407521
Misoprosotol and Isosorbide Mononitrate for Induction of Second Trimester Abortion
A Phase 4 study testing Misoprostol and isosorbide mononitrate in people with Second Trimester Abortion, run by Ain Shams University at 1 site in Egypt.
Trial summary
the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Second Trimester Abortion
- What is being tested?
- Misoprostol and isosorbide mononitrate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Apr 2017to 15 Dec 2017
- Phase
- Phase 4
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age 16 -40 years
- Missed abortion
- Singelton pregnancy
- Gestationl age between 13 and 26 weeks of pregnancy
- Normal uterus and cevix on clinical examination
- Cervix is not dilatated
Show all 9Show fewer
- No uterine activity and vaginal bleeding
- Written and informed consent by the patient
- Unscarred uterus
Who cannot join
- Presence of uterine contraction or bleeding
- Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
- Multifetal pregnancy
- Suspicion of septic abortion
- History of cervical surgery or manipulation
- Uterine anomaly
Show all 10Show fewer
- IUD in situ
- Associtaed hemorrhagic disorder
- History of adverse effects to vaginally adminstered medication
- Inability to insert vaginal medication high in vagina
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion
the investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.
the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.
Read the detailed description
the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.
In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.
The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.
The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.
- Conditions
- Second Trimester Abortion
- Being tested
- Misoprostol, isosorbide mononitrate, Placebo
- Keywords
- second trimester abortion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
induction of abortion using misoprostol
isosorbide mononitrateDrug
isosorbide mononitrate
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | misoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once Receives: Drug: Misoprostol; Drug: isosorbide mononitrate |
| control group | Placebo comparator | misoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo Receives: Drug: Misoprostol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
induction abortion interval
time needed to induce abortion in second trimester abortion
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start12 Apr 2017
- Primary completion22 Oct 2017
- Study completion15 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Second Trimester AbortionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed abd elfatah elsenity, Ain Shams University
- Investigators
- mohamed ab elsenity, MD, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407521
- Sponsor's protocol ID
- R02 MH12345
- Status last verified
- Feb 2018
- First submitted
- 16 Jan 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: publish in scientific journals
Publications
Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. doi: 10.1016/s0002-9378(96)70270-3.
PubMed 8694046
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Response of Adding Isosorbide Mononitrate to Misoprostol in Induction of Second Trimester Abortion
- ClinicalTrials.gov ID
- NCT03407521
- Acronym / sponsor ID
- R02 MH12345
- Conditions
- Second Trimester Abortion
- Keywords
- second trimester abortion
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 12 Apr 2017 (actual)
- Primary completion
- 22 Oct 2017 (actual)
- Study completion
- 15 Dec 2017 (actual)
- First posted
- 23 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 investigators aimed to study the efficacy and safety of nitric oxide donors when combined with prostaglandins in induction of second trimester abortion expecting that both drugs when used together will be of greater efficiency and associated with less side effects.
the study included 60 women with gestational age between 13weeks+0day and 26weeks+6days indicated for pregnancy termination due to maternal or fetal cause.
Detailed description
the study aimed to compare the effect of isosorbid mononitrate when combined with misoprostol and misoprostol when used alone in second trimester abortion, expecting that both drugs when used together will be more effective and associated with fewer side effects.
In this study 60 women were enrolled, divided into two groups. The first group (group I), 30 women received misoprostol and isosorbid mononitrate.
The second group (group II), 30 women received misoprostol and placebo. The primary aim of the study was the occurrence of complete abortion in the first 24 hours.
The study concluded that the combination of isosorbid mononitrate with misoprostol is more effective in second trimester abortion than misoprostol with placebo, but is associated with more side effects mainly headache.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | Active comparator | Drug: Misoprostol, Drug: isosorbide mononitratemisoprostol tab 200mcg 2 tab at first then one every 4 hours with isosorbide mononitrate 20mg once |
| control group | Placebo comparator | Drug: Misoprostol, Drug: Placebomisoprostol tab 200mcg 2 tab at first then one every 4 hours with placebo |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age 16 -40 years
- Missed abortion
- Singelton pregnancy
- Gestationl age between 13 and 26 weeks of pregnancy
- Normal uterus and cevix on clinical examination
Key exclusion criteria (10 listed)
- Presence of uterine contraction or bleeding
- Evidences suggesting of onset of spontaneous abortion as Previous trial to induce abortion
- Multifetal pregnancy
- Suspicion of septic abortion
- History of cervical surgery or manipulation
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 |
|---|---|---|
| Misoprostolinduction of abortion using misoprostol | Drug | control group, study group |
| isosorbide mononitrateisosorbide mononitrate | Drug | study group |
| PlaceboPlacebo | Drug | control group |
Primary outcome
induction abortion interval
Time frame: 24 hours
time needed to induce abortion in second trimester abortion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Results publication: PubMed 8694046Jain JK, Mishell DR Jr. A comparison of misoprostol with and without laminaria tents for induction of second-trimester abortion. Am J Obstet Gynecol. 1996 Jul;175(1):173-7. doi: 10.1016/s0002-9378(96)70270-3.
- Individual participant dataSharing planned: No. publish in scientific journals
Related trials for Second Trimester Abortion
Not yet recruitingPhase 1/2
Second Trimester Abortion With Letrozole and Misoprostol Compared to Misoprostol Alone
Abortion Induced Complicated, Abortion
RecruitingPhase 2
Paracervical Block With Combined Ketorolac and Lidocaine for Osmotic Dilator Placement
Pain Management, Abortion
Recruiting
Cervical Preparation for Same-Day Dilation & Evacuation
Abortion, Second Trimester, Procedural Pain
RecruitingPhase 4
Tranexamic Acid for Second Trimester Dilation and Evacuation and Bleeding Outcomes
Abortion, Dilation and Evacuation
Recruiting
Foley Balloon for Cervical Preparation Before Dilation and Evacuation
Abortion, Second Trimester, Abortion, Medical
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.
mohamed ab elsenity, MD principal investigator
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol and isosorbide mononitrate in people with Second Trimester Abortion, run by Ain Shams 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 28 Feb 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
induction abortion interval (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03407521, which also lists 1 linked publication.
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 28 Feb 2018.