Induction of AbortionPhase 4ObstetricsNCT07465016

Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus

A Phase 4 study testing Misoprostol ( Cytotec) 200 microgram a tablet and Laminaria Tent in people with Induction of Abortion and Scarred Uterus, run by Pavly Maged Jimmy Fouad at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to compare the induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus. Read more about this study

Who is it for?: Ages 18 to 45 years, women only
Conditions the study is for: Induction of Abortion, Scarred Uterus
What is being tested?: Misoprostol ( Cytotec) 200 microgram a tablet and Laminaria Tent
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteEgypt
Study dates: 10 Jan 2023to 25 Jan 2025
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 18 to 45 years
Women only
No healthy volunteers
Adult

Who may be able to join

Age range 18-45 years old.
Women with previous scarred uterus.
Presence of an indication for induction of abortion.
Estimated gestational age between 13-26 weeks as calculated from last normal menstrual period (LMP) and confirmed by abdominal ultrasound.

Who cannot join

Primigravida women.
Pregnant women with placenta previa accreta spectrum.
Women with diagnosed cervical cancer.
History of cervical surgery or presence of cervical scarring.
Presence of allergy to any of the used drugs in the study.
Women withdraws or declines to participate in this study.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

Ain Shams Maternity Hospital
Cairo

Other trials in Egypt

About this study

Official title: Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus: A Randomized Comparative Trial

Is the usage of laminaria japonicum as a mechanical dilator for the cervix followed by Prostaglandin E1 more effective and time saving than using prostaglandin E1 alone in induction of mid-trimester abortion in a previously scarred uterus? Researchers will compare induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus.

Participants in Group A: induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Participants in Group B: induction of abortion will be carried out by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Conditions: Induction of Abortion, Scarred Uterus
Being tested: Misoprostol ( Cytotec) 200 microgram a tablet, Laminaria Tent
Keywords: Obstetrics, Abortion, Second trimester, Laminaria, Misoprostol

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Misoprostol ( Cytotec) 200 microgram a tabletDrug
30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
Laminaria TentDrug
Laminaria Tent will be used for induction of abortion

Study groups in NCT07465016
Study group	Role	What they receive
Laminaria japonicum to be followed by Misoprostol	Active comparator	Induction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. Receives: Drug: Misoprostol ( Cytotec) 200 microgram a tablet; Drug: Laminaria Tent
Misoprostol only	Active comparator	Induction of abortion will be carried out only by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation. Receives: Drug: Misoprostol ( Cytotec) 200 microgram a tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Induction-to-abortion interval time.
Time taken from the start of induction of abortion till occurrence of abortion
Measured: From enrollment to the end of abortion, an average of one week

Secondary outcomes (4)

Rate of Operative intervention
Operative intervention needed as suction \& evacuation or the need for hystrotomy
Measured: From enrollment to the end of abortion, an average of one week
Amount of vaginal bleeding
The amount of vaginal bleeding with be assessed visually and categorized into mild, moderate \& severe.
Measured: From enrollment to the end of abortion, an average of one week
Rate of occurrence of uterine rupture followed by hysterectomy
As a complication of the usage of Misoprostol in previous scarred uterus is uterine rupture
Measured: From enrollment to the end of abortion, an average of one week
The amount of Misoprostol doses needed (microgram)
The doses of Misoprostol needed till expulsion of the fetus in each arm will be compared
Measured: Group A: after removal of Laminaria till expulsion of the fetus, an average of one week while for Group B: From enrollment to the end of abortion, an average of one week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jan 202325 Jan 2025

First posted11 Mar 2026
Study start10 Jan 2023
Primary completion10 Jan 2025
Study completion25 Jan 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Induction of AbortionStudies of the same condition, open and under way.
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
Model description: Two arm randomized comparative study.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07465016
Sponsor's protocol ID: FMASU MD 45/2023
Acronym: Obstetrics
Status last verified: Feb 2026
First submitted: 9 Feb 2026
Last updated: 11 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

Publications

Sagiv R, Mizrachi Y, Glickman H, Kerner R, Keidar R, Bar J, Golan A. Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial. Contraception. 2015 May;91(5):406-11. doi: 10.1016/j.contraception.2015.01.018. Epub 2015 Jan 31.
PubMed 25646929
El Maradny E, Kanayama N, Halim A, Maehara K, Kobayashi T, Terao T. Biochemical changes in the cervical mucus after application of laminaria tent. Acta Obstet Gynecol Scand. 1996 Mar;75(3):203-7. doi: 10.3109/00016349609047087.
PubMed 8607329
Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25.
PubMed 31281014
Joob B and Wiwanitkti V (2016): Laminaria species and usefulness in obstetrics and gynaecology. Journal of Coastal Life Medicine, 2016; 4(3):244-5.
Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
PubMed 24331860
Clouqueur E, Coulon C, Vaast P, Chauvet A, Deruelle P, Subtil D, Houfflin-Debarge V. [Use of misoprostol for induction of labor in case of fetal death or termination of pregnancy during second or third trimester of pregnancy: Efficiency, dosage, route of administration, side effects, use in case of uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):146-61. doi: 10.1016/j.jgyn.2013.11.008. Epub 2014 Jan 22. French.
PubMed 24461423
Chodankar R, Gupta J, Gdovinova D, Bovo MJ, Hanacek J, Kan N, Roizin J, Tyutyunnik V. Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:249-254. doi: 10.1016/j.ejogrb.2018.07.013. Epub 2018 Jul 11.
PubMed 30032065
Cetin C, Buyukkurt S, Seydaoglu G, Kahveci B, Soysal C, Ozgunen FT. Comparison of two misoprostol regimens for mid-trimester pregnancy terminations after FIGO's misoprostol dosage recommendation in 2012. J Matern Fetal Neonatal Med. 2016;29(8):1314-7. doi: 10.3109/14767058.2015.1046831. Epub 2015 Jun 11.
PubMed 26067264
Bertholdt C, David MG, Gabriel P, Morel O, Perdriolle-Galet E. Effect of the addition of osmotic dilators to medical induction of labor abortion: A before-and-after study. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:185-189. doi: 10.1016/j.ejogrb.2019.10.013. Epub 2019 Oct 21.
PubMed 31771801
Barinov SV, Tirskaya YI, Shamina IV, Medyannikova IV, Kadcyna TV, Shkabarnya LL, Lazareva OV. The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage. J Matern Fetal Neonatal Med. 2021 Sep;34(17):2778-2782. doi: 10.1080/14767058.2019.1671331. Epub 2019 Oct 1.
PubMed 31570024
Achenbach AE, Singh S, Jackson B, Caveglia SJ, Berghella V, Seligman NS. Cervical ripening with laminaria tents prior to second trimester induction of labor. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5807-5812. doi: 10.1080/14767058.2021.1893297. Epub 2021 May 24.
PubMed 34030560
Abdallah M, Moheb A, Mousa AB, Saleh AM (2022): Comparison between Mechanical induced Cervical Dilatation in Previous Scar Woman in 2nd Trimester Abortion: Non-Randomized Controlled Study. Minia Journal of Medical Research, 2022; 33(1):44-9.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Induction of Abortion trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Laminaria Japonicum Followed by Misoprostol Versus Misoprostol Alone for Mid-Trimester Abortion Induction in Scarred Uterus: A Randomized Comparative Trial
ClinicalTrials.gov ID: NCT07465016
Acronym / sponsor ID: Obstetrics / FMASU MD 45/2023
Conditions: Induction of Abortion, Scarred Uterus
Keywords: Obstetrics, Abortion, Second trimester, Laminaria, Misoprostol
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Pavly Maged Jimmy FouadUniversity, hospital or other
Collaborators: Ain Shams Maternity Hospital
Study start: 10 Jan 2023 (actual)
Primary completion: 10 Jan 2025 (actual)
Study completion: 25 Jan 2025 (actual)
First posted: 11 Mar 2026 (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.

Is the usage of laminaria japonicum as a mechanical dilator for the cervix followed by Prostaglandin E1 more effective and time saving than using prostaglandin E1 alone in induction of mid-trimester abortion in a previously scarred uterus? Researchers will compare induction-to-abortion time interval between women receiving Laminaria tent followed by misoprostol and those receiving misoprostol alone for mid-trimester abortion induction in women with a scarred uterus.

Participants in Group B: induction of abortion will be carried out by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Two arm randomized comparative study.

Arm	Type	Receives
Laminaria japonicum to be followed by Misoprostol	Active comparator	Drug: Misoprostol ( Cytotec) 200 microgram a tablet, Drug: Laminaria TentInduction of abortion will be started with insertion of Laminaria japonicum for 12 hours to be followed by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
Misoprostol only	Active comparator	Drug: Misoprostol ( Cytotec) 200 microgram a tabletInduction of abortion will be carried out only by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Who may qualify

Ages: 18 to 45 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Age range 18-45 years old.
Women with previous scarred uterus.
Presence of an indication for induction of abortion.
Estimated gestational age between 13-26 weeks as calculated from last normal menstrual period (LMP) and confirmed by abdominal ultrasound.

Key exclusion criteria (6 listed)

Primigravida women.
Pregnant women with placenta previa accreta spectrum.
Women with diagnosed cervical cancer.
History of cervical surgery or presence of cervical scarring.
Presence of allergy to any of the used drugs in the study.

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
Misoprostol ( Cytotec) 200 microgram a tablet30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.	Drug	Laminaria japonicum to be followed by Misoprostol, Misoprostol only
Laminaria TentLaminaria Tent will be used for induction of abortion	Drug	Laminaria japonicum to be followed by Misoprostol

Primary outcome

Induction-to-abortion interval time.
Time frame: From enrollment to the end of abortion, an average of one week
Time taken from the start of induction of abortion till occurrence of abortion

4 secondary outcomes

Rate of Operative intervention
Time frame: From enrollment to the end of abortion, an average of one week
Amount of vaginal bleeding
Time frame: From enrollment to the end of abortion, an average of one week
Rate of occurrence of uterine rupture followed by hysterectomy
Time frame: From enrollment to the end of abortion, an average of one week
The amount of Misoprostol doses needed (microgram)
Time frame: Group A: after removal of Laminaria till expulsion of the fetus, an average of one week while for Group B: From enrollment to the end of abortion, an average of one week

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 11 Mar 2026.
Background: PubMed 25646929Sagiv R, Mizrachi Y, Glickman H, Kerner R, Keidar R, Bar J, Golan A. Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial. Contraception. 2015 May;91(5):406-11. doi: 10.1016/j.contraception.2015.01.018. Epub 2015 Jan 31.
Background: PubMed 8607329El Maradny E, Kanayama N, Halim A, Maehara K, Kobayashi T, Terao T. Biochemical changes in the cervical mucus after application of laminaria tent. Acta Obstet Gynecol Scand. 1996 Mar;75(3):203-7. doi: 10.3109/00016349609047087.
Background: PubMed 31281014Lerma K, Blumenthal PD. Current and potential methods for second trimester abortion. Best Pract Res Clin Obstet Gynaecol. 2020 Feb;63:24-36. doi: 10.1016/j.bpobgyn.2019.05.006. Epub 2019 May 25.
BackgroundJoob B and Wiwanitkti V (2016): Laminaria species and usefulness in obstetrics and gynaecology. Journal of Coastal Life Medicine, 2016; 4(3):244-5.
Background: PubMed 24331860Fox MC, Krajewski CM. Cervical preparation for second-trimester surgical abortion prior to 20 weeks' gestation: SFP Guideline #2013-4. Contraception. 2014 Feb;89(2):75-84. doi: 10.1016/j.contraception.2013.11.001. Epub 2013 Nov 11.
Background: PubMed 24461423Clouqueur E, Coulon C, Vaast P, Chauvet A, Deruelle P, Subtil D, Houfflin-Debarge V. [Use of misoprostol for induction of labor in case of fetal death or termination of pregnancy during second or third trimester of pregnancy: Efficiency, dosage, route of administration, side effects, use in case of uterine scar]. J Gynecol Obstet Biol Reprod (Paris). 2014 Feb;43(2):146-61. doi: 10.1016/j.jgyn.2013.11.008. Epub 2014 Jan 22. French.
Background: PubMed 30032065Chodankar R, Gupta J, Gdovinova D, Bovo MJ, Hanacek J, Kan N, Roizin J, Tyutyunnik V. Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:249-254. doi: 10.1016/j.ejogrb.2018.07.013. Epub 2018 Jul 11.
Background: PubMed 26067264Cetin C, Buyukkurt S, Seydaoglu G, Kahveci B, Soysal C, Ozgunen FT. Comparison of two misoprostol regimens for mid-trimester pregnancy terminations after FIGO's misoprostol dosage recommendation in 2012. J Matern Fetal Neonatal Med. 2016;29(8):1314-7. doi: 10.3109/14767058.2015.1046831. Epub 2015 Jun 11.
Background: PubMed 31771801Bertholdt C, David MG, Gabriel P, Morel O, Perdriolle-Galet E. Effect of the addition of osmotic dilators to medical induction of labor abortion: A before-and-after study. Eur J Obstet Gynecol Reprod Biol. 2020 Jan;244:185-189. doi: 10.1016/j.ejogrb.2019.10.013. Epub 2019 Oct 21.
Background: PubMed 31570024Barinov SV, Tirskaya YI, Shamina IV, Medyannikova IV, Kadcyna TV, Shkabarnya LL, Lazareva OV. The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage. J Matern Fetal Neonatal Med. 2021 Sep;34(17):2778-2782. doi: 10.1080/14767058.2019.1671331. Epub 2019 Oct 1.
Background: PubMed 34030560Achenbach AE, Singh S, Jackson B, Caveglia SJ, Berghella V, Seligman NS. Cervical ripening with laminaria tents prior to second trimester induction of labor. J Matern Fetal Neonatal Med. 2022 Dec;35(25):5807-5812. doi: 10.1080/14767058.2021.1893297. Epub 2021 May 24.
BackgroundAbdallah M, Moheb A, Mousa AB, Saleh AM (2022): Comparison between Mechanical induced Cervical Dilatation in Previous Scar Woman in 2nd Trimester Abortion: Non-Randomized Controlled Study. Minia Journal of Medical Research, 2022; 33(1):44-9.
Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in obstetrics. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

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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.

Amr Fathy Ahmed, Professor study chair

Ain Shams Maternity Hospital

Mohamed ElMandouh Mohamed, Professor study chair

Ain Shams Maternity Hospital

Haitham Mohamed Sabaa, Professor study chair

Ain Shams Maternity Hospital

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 ( Cytotec) 200 microgram a tablet and Laminaria Tent in people with Induction of Abortion and Scarred Uterus, run by Pavly Maged Jimmy Fouad 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 4 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: finished, as of the sponsor's last update on 11 Mar 2026. 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.

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-to-abortion interval time. (time frame: From enrollment to the end of abortion, an average of one week). 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 NCT07465016, which also lists 12 linked publications.

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 11 Mar 2026.