Clinical trial NCT06818903: Misoprostol in Missed Abortion
Official title: Misoprostol Versus Intracervical Foley's Catheter for Termination of Second Trimester Abortion
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Abortion; Attempted
Keywords: Abortion
Misopristol
Foley catheter
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are indicated for termination of pregnancy in second trimester due to fetal abnormalities and intrauterine fetal death

Brief summary: In this study we compare between the effectiveness of combined Foley's catheter with Misoprostol and intracervical Foley's catheter alone for termination of second trimester abortion.

Detailed description: Termination of pregnancy (TOP) is defined as elective expulsion or extraction of products of conception from uterus instead of spontaneous onset of process irrespectable of duration of pregnancy. Worldwide mid-trimester abortion constitutes 10-15% of all induced abortions but responsible for two-thirds of all major complications Despite the recent advances in prenatal diagnosis in first trimester. Termination of pregnancy in second trimester due to foetal abnormalities and intrauterine foetal death still accounts for large number of abortions, and has increased the demand for rapid termination of pregnancy. In intrauterine fetal death in 2nd trimester, expulsion may take several weeks. This is associated with psychological trauma, coagulopathy and intrauterine infection. Among various methods of second trimester termination, evacuation and curettage induces risk of bleeding, infection, uterine perforation and cervical trauma. The introduction of misoprostol , a synthetic prostaglandin E1 analogue (PGE1) has become an important for cervical ripening and uterotonic action. It is economic, stable at room temperature and is associated with few side effects such as fever, vomiting and diarrhea. There is still debate about doses, routes and regimes of PGE1 for termination of pregnancy during 2nd trimester. It is active orally but more effective and better tolerated when administrated vaginally and has fewer side effects. Vaginal route is preferred in first and second trimester. The use of Foley's catheter has been recommended in many developing countries. The reports from different countries have mentioned excellent results with the use of Foley's catheter either alone or in combination with prostaglandins. The scope of our study: is to compare the use of Foley's catheter combination with Misoprostol versus Foley's catheter alone for pre induction cervical ripening and induction of second trimester abortion.

Eligibility criteria: Inclusion Criteria:

* Women aged between 18 - 40 years of age with mid-trimester fetal death inutero.

  * Singleton pregnancies from 18-24 weeks.
  * women with unfavourable cervix (Bishop Score \< 5) at the time of recruitment.
  * Previous one CS and non-previous CS pregnant women.

Exclusion Criteria:

* • Previous 2 CS or more.

  * Medical contraindications for prostaglandin therapy (allergy to prostaglandins or severe asthma).
  * co-morbidities like severe anemia (Hb \< 7g/dl), hypertension, diabetes, or coagulopathy .
  * Women with excessive vaginal discharge or rupture of membrane.
  * Women having any complication in previous caesarean like endometritis, reopening, scar dehiscence etc.
  * Active genital infection e. g. active genital Herpes simplex infection.

Primary outcomes:
measure: Interval time
timeFrame: periprocedurally
Secondary outcomes:
Other outcomes:
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Study officials:
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