Missed Abortion
Conditions
Keywords
Oral misoprostol, First Trimester, Vaginal misoprostol
Brief summary
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.
Interventions
DRUGOral misoprostol
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.
Sponsors
Hamna Khaliq
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Parity \<5 * Presenting with missed abortion (defined as spontaneous loss of pregnancy, presence of lower abdomen cramps, ultrasound scan shows no fetal cardiac activity during 8-16 weeks of pregnancy)
Exclusion criteria
* Pregnancy with any degree of cervical dilatation * Signs or symptoms of infection, * Twin gestation sac, molar pregnancy (on ultrasound), * Excessive uterine bleeding, * Blood pressure ≥160/90 mmHg, * Maternal history of asthma or cardiac or cerebral disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Induction to Expulsion Interval | 48 hours | Induction to expulsion interval is assessed in terms of hours required to expel the conception material. |
| Efficacy of Oral Versus Vaginal route | 24 hours | Efficacy assessed on the basis that no retained conception material in uterus detected on ultrasound after 24 hours of induction |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Oral Misoprostol versus Vaginally administered Misoprostol | 48hours | 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) |
Countries
Pakistan
Contacts
CONTACTDr Hamna Khaliq, MBBS
Outcome results
None listed