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

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

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. The main question it aims to answer is:

• 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.

Study Overview

• Status: Completed
• Conditions: Scarred Uterus; Induction of Abortion
• Intervention / Treatment: Drug: Misoprostol ( Cytotec) 200 microgram a tablet; Drug: Laminaria Tent

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ain Shams Maternity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Laminaria japonicum to be followed by Misoprostol; 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.	Drug: Misoprostol ( Cytotec) 200 microgram a tablet; 30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.; Drug: Laminaria Tent; Laminaria Tent will be used for induction of abortion
Active Comparator: Misoprostol only; Induction of abortion will be carried out only by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.	Drug: Misoprostol ( Cytotec) 200 microgram a tablet; 30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Operative intervention	Operative intervention needed as suction & evacuation or the need for hystrotomy	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.	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	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	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

Collaborators and Investigators

• Sponsor: Pavly Maged Jimmy Fouad
• Collaborators: Ain Shams Maternity Hospital
• Investigators: Study Chair: Amr Fathy Ahmed, Professor, Ain Shams Maternity Hospital; Study Chair: Mohamed ElMandouh Mohamed, Professor, Ain Shams Maternity Hospital; Study Chair: Haitham Mohamed Sabaa, Professor, Ain Shams Maternity Hospital; Study Chair: Hamdy Bakry Alqenawy, Lecturer, Ain Shams Maternity Hospital

Publications and helpful links

General Publications

• Sagiv R, Mizrachi Y, Glickman H, Kerner R, Keidar R, Bar J (2015): Laminaria vs vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial. Contraception, 2015; 91(5):406-11.
• Maradny EE, Kanayama N, Halim A, Maehara K, Kobayashi T, Terao T (1996): Biochemical changes in the cervical mucus after application of laminaria tent. Acta Obstetricia et Gynaecologica Scandinavica, 1996; 75(3):203-7.
• Lerma K and Blumenthal PD (2020): Current and potential methods for second trimester abortion. Best practice & Research Clinical Obstetrics & Gynaecology, 2020; 63:24-36.
• 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 and Krajewski CM (2014): Cervical preparation for second-trimester surgical abortion prior to 20 weeks gestation. Contraception, 2014; 89(2):75-84.
• Clouqueur E, Coulon C, Vaast P, Chauvet A, Deruelle P, Subtil D and Houfflin-Debarge V (2014): Use of misoprostol for induction of labor in case of fetal death or termination of pregnancy during second or third trimester of pregnancy. J Gynecol Obstet Biol Reprod (Paris), 2014; 43(2):146-61.
• Chodankar R, Gupta J, Gdovinova D, Bovo MJ, Hanacek J, Kan N, Roizin J and Tyutyunnik V (2018): Synthetic osmotic dilators for cervical preparation prior to abortion: An international multicentre observational study. Eur J Obstet Gynecol Reprod Biol, 2018; 228:249-254.
• Cetin C, Buyukkurt S, Seydaoglu G, Kahveci B, Soysal C and Ozgunen FT (2016): 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.
• Bertholdt C, David MG, Gabriel P, Morel O and Perdriolle-Galet E (2020): Effect of the addition of osmotic dilators to medical induction of labor & abortion: A before-and-after study. European Journal of Obstetrics & Gynaecology and Reproductive Biology, 2020; 244:185-189.
• Barinov SV, Tirskaya YI, Shamina IV, Medyannikova IV, Kadcyna TV, Shkabarnya LL and Lazareva OV (2021): The use of an osmotic dilator for induction of miscarriage in patients with the second trimester missed miscarriage. The Journal of Maternal-Fetal & Neonatal Medicine, 2021; 34(17):2778-2782.
• Achenbach AE, Singh S, Jackson B, Caveglia SJ, Berghella V, Seligman NS (2022): Cervical ripening with Laminaria tents prior to second trimester induction of labour. The Journal of Maternal-Fetal & Neonatal Medicine, 2022; 35(25):5807-12.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2023
• Primary Completion (Actual): January 10, 2025
• Study Completion (Actual): January 25, 2025

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: March 9, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Obstetrics; Misoprostol; Abortion; Laminaria; Second trimester
• Additional Relevant MeSH Terms: Fatty Acids; Lipids; Biological Factors; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Autacoids; Inflammation Mediators; Prostaglandins E, Synthetic; Misoprostol
• Other Study ID Numbers: FMASU MD 45/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• IPD Sharing Access Criteria: Access to trial IPD can be requested by qualified researchers engaging in independent scientific research and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA).
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes