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Completed

NCT Number: NCT07465016

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

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.

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Key information

Conditions

Induction of Abortion Scarred Uterus

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Ain Shams Maternity Hospital

Cairo, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Misoprostol ( Cytotec) 200 microgram a tablet

Drug

30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.

Laminaria Tent

Drug

Laminaria Tent will be used for induction of abortion

Primary outcomes

  1. 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

Secondary outcomes

  1. Rate of Operative intervention

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

    Operative intervention needed as suction & evacuation or the need for hystrotomy

  2. Amount of vaginal bleeding

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

    The amount of vaginal bleeding with be assessed visually and categorized into mild, moderate & severe.

  3. Rate of occurrence of uterine rupture followed by hysterectomy

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

    As a complication of the usage of Misoprostol in previous scarred uterus is uterine rupture

  4. 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

    The doses of Misoprostol needed till expulsion of the fetus in each arm will be compared

Sponsors and collaborators

Lead sponsor

Pavly Maged Jimmy Fouad

Other

Collaborators

  • Ain Shams Maternity Hospital

Registry information

Official study title

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

Acronym: Obstetrics

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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