A Phase 1 interventional study of Oral misoprostol and Misoprostol (given vaginally) in Missed Abortion, sponsored by Hamna Khaliq. Not yet recruiting at 1 site in Pakistan. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Hamna Khaliq · Phase 1, Interventional, and Treatment
Incomplete abortion has an eminent clinical diagnosis and is characterized by transvaginal bleeding associated with an open uterine cervix upon physical examination when the products of conception have not been wholly discharged. This is the most frequent clinical presentation of this condition. Currently, misoprostol (prostaglandin E2 analog), along with mifepristone, is the reference drug for medicated uterine emptying in cases of spontaneous or induced abortion, both in the first gestational trimester and at more advanced gestational ages.Misoprostol-only is a safe and effective option for females with missed abortion in the first trimester, although less effective than standard regimens that also contain mifepristone.Once the efficacy, safety, and acceptability of misoprostol in incomplete abortion are well established, future studies must be done in finding the ideal route of administration (oral, sublingual, or vaginal), perfect dosage, and intervals of administration when necessary.
The purpose of this study is to evaluate the safety and effectiveness of oral versus vaginal misoprostol in cases of missed abortions during the first trimester of pregnancy. Misoprostol is widely used for medical management of early pregnancy loss; however, the optimal route of administration remains uncertain. Comparing these two routes may help identify the most effective and safest method, thereby improving patient outcomes and guiding clinical practice. According to literature, misoprostol administered vaginally has better effectiveness and fewer side effects. However, conflicting evidence has been found in literature that indicates there is no difference between both route for misoprostol administration. In order to determine the best course of action with the fewest adverse effects for women who have missed an abortion, we wish to carry out this experiment. In order to apply the more appropriate route to the local community, adopt a more effective approach, and revise the criteria for doing so. This will enhance our expertise and methods as well as will improve patients' satisfaction will treatment.
48 studies on the registry are indexed under Abortion, Missed; 10 are open to participants now.
This study's planned enrollment of 100 is close to the median of 110 across 41 interventional studies indexed under Abortion, Missed.
Browse Abortion, Missed studies →This is the only study on the registry with Hamna Khaliq as lead sponsor.
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Exclusion Criteria:
After obtaining informed consent and demographic information, anemia, previous abortion, use of intrauterine contraceptive device, history of taking hormonal treatment, in-vitro fertilization) will be recorded. Then females will be randomly divided in two groups by using lottery method. In group A, 50 females will be given 400 µg Misoprostol orally, maximum of 3 doses.Then females will be followed-up in labor room until expulsion of conception material Induction to expulsion interval will be noted. After expulsion, females will undergo ultrasonography by a senior sonologist with assistance of researcher. If there will be no retained conception material in uterus, then efficacy will be labeled. Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect including nausea, vomiting, headache, diarrhea,fever and rash. All this Information will be recorded in proforma.
Drug: Oral misoprostol
After obtaining informed consent and demographic information, anemia, previous abortion, use of intrauterine contraceptive device, history of taking hormonal treatment, in-vitro fertilization) will be recorded. Then females will be randomly divided in two groups by using lottery method. In group B, 50 females will be given 400 µg Misoprostol vaginally at maximum of 3 doses.Then females will be followed-up in labor room until expulsion of conception material Induction to expulsion interval will be noted. After expulsion, females will undergo ultrasonography by a senior sonologist with assistance of researcher. If there will be no retained conception material in uterus, then efficacy will be labeled. Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect including nausea, vomiting, headache, diarrhea,fever and rash. All this Information will be recorded in proforma.
Drug: Misoprostol (given vaginally)
In group A, females will be given 400 µg orally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.
In group B, females will be given 400 µg vaginally, maximum of 3 doses.Females will be shifted to post-delivery wards and will be followed-up there for 48 hours for assessment of any adverse effect.
Induction to Expulsion Interval
Induction to expulsion interval is assessed in terms of hours required to expel the conception material.
Time frame: 48 hours
Efficacy of Oral Versus Vaginal route
Efficacy assessed on the basis that no retained conception material in uterus detected on ultrasound after 24 hours of induction
Time frame: 24 hours
Safety of Oral Misoprostol versus Vaginally administered Misoprostol
Safety is assessed in terms of absence of any adverse event including nausea and vomiting (\>3 episodes per week), headache, diarrhea (\>3 loose stools), fever (\>100oF), and rash (redness and itching on skin)
Time frame: 48hours
Plan to share: No
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Start is estimated for May 2026; primary completion for Jul 2026, 2 months later.
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Studies of the drug tested here: Misoprostol