Induction of Abortion, Scarred Uterus
Conditions
Keywords
Obstetrics, Abortion, Second trimester, Laminaria, Misoprostol
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.
Interventions
30 women will have induction of abortion by prostaglandin E1 methyl analogue, Misoprostol according to the FIGO 2017 recommendation.
DRUGLaminaria Tent
Laminaria Tent will be used for induction of abortion
Sponsors
Pavly Maged Jimmy Fouad
Ain Shams Maternity Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Two arm randomized comparative study.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction-to-abortion interval time. | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Operative intervention | From enrollment to the end of abortion, an average of one week | Operative intervention needed as suction \& evacuation or the need for hystrotomy |
| Amount of vaginal bleeding | 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. |
| Rate of occurrence of uterine rupture followed by hysterectomy | 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 |
| 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 | The doses of Misoprostol needed till expulsion of the fetus in each arm will be compared |
Countries
Egypt
Contacts
STUDY_CHAIRAmr Fathy Ahmed, Professor
Ain Shams Maternity Hospital
STUDY_CHAIRMohamed ElMandouh Mohamed, Professor
Ain Shams Maternity Hospital
STUDY_CHAIRHaitham Mohamed Sabaa, Professor
Ain Shams Maternity Hospital
STUDY_CHAIRHamdy Bakry Alqenawy, Lecturer
Ain Shams Maternity Hospital
Outcome results
None listed