NCT07465016

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2025

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

February 9, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 11, 2026

Completed
Last Updated

March 11, 2026

Status Verified

February 1, 2026

Enrollment Period

2 years

First QC Date

February 9, 2026

Last Update Submit

March 9, 2026

Conditions

Induction of AbortionScarred Uterus

Keywords

ObstetricsAbortionSecond trimesterLaminariaMisoprostol

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Rate of Operative intervention

    From enrollment to the end of abortion, an average of one week

  • Amount of vaginal bleeding

    From enrollment to the end of abortion, an average of one week

  • Rate of occurrence of uterine rupture followed by hysterectomy

    From enrollment to the end of abortion, an average of one week

  • The amount of Misoprostol doses needed (microgram)

    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

Study Arms (2)

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.

Drug: Misoprostol ( Cytotec) 200 microgram a tabletDrug: 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.

Drug: Misoprostol ( Cytotec) 200 microgram a tablet

Interventions

Laminaria TentDRUG

Laminaria Tent will be used for induction of abortion

Laminaria japonicum to be followed by Misoprostol
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 japonicum to be followed by MisoprostolMisoprostol only

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPregnant women who will be admitted to Ain Shams University Maternity Hospital for induction of mid-trimester abortion.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ain Shams Maternity Hospital

Cairo, Egypt

Location

Related Publications (12)

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • Lerma K and Blumenthal PD (2020): Current and potential methods for second trimester abortion. Best practice & Research Clinical Obstetrics & Gynaecology, 2020; 63:24-36.

    BACKGROUND

  • Joob B and Wiwanitkti V (2016): Laminaria species and usefulness in obstetrics and gynaecology. Journal of Coastal Life Medicine, 2016; 4(3):244-5.

    BACKGROUND

  • Fox MC and Krajewski CM (2014): Cervical preparation for second-trimester surgical abortion prior to 20 weeks gestation. Contraception, 2014; 89(2):75-84.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • 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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arm randomized comparative study.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Lecturer of Obstetrics and Gynecology at Ain Shams University

Study Record Dates

First Submitted

February 9, 2026

First Posted

March 11, 2026

Study Start

January 10, 2023

Primary Completion

January 10, 2025

Study Completion

January 25, 2025

Last Updated

March 11, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
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.
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).

Locations

EG(1)