Missed AbortionPhase 1NCT07526064
Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy
A Phase 1 study testing Oral misoprostol and Misoprostol (given vaginally) in people with Missed Abortion, run by Hamna Khaliq at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Missed Abortion
- What is being tested?
- Oral misoprostol and Misoprostol (given vaginally)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 May 2026to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
PNS Hafeez
Islamabad, 44000
Dr Naureen Ghani, MBBS, FCPS, +923151764864, msnghani@gmail.com
About this study
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.
- Conditions
- Missed Abortion
- Being tested
- Oral misoprostol, Misoprostol (given vaginally)
- Keywords
- Oral misoprostol, First Trimester, Vaginal misoprostol
- Medical subject headings
- Abortion, Missed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral misoprostolDrug
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.
Misoprostol (given vaginally)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 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. Receives: Drug: Oral misoprostol |
| Group B | Active comparator | 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. Receives: Drug: Misoprostol (given vaginally) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction to Expulsion Interval
Induction to expulsion interval is assessed in terms of hours required to expel the conception material.
Measured: 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
Measured: 24 hours
Secondary outcomes (1)
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)
Measured: 48hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Missed AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamna Khaliq
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Hamna Khaliq, PNS Hafeez - Naval Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526064
- Sponsor's protocol ID
- 27
- Status last verified
- Apr 2026
- First submitted
- 6 Apr 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy and Safety of Oral Versus Vaginal Misoprostol in Missed Abortion in First Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT07526064
- Acronym / sponsor ID
- 27
- Conditions
- Missed Abortion
- Keywords
- Oral misoprostol, First Trimester, Vaginal misoprostol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hamna KhaliqOther government
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Oral misoprostolAfter 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. |
| Group B | Active comparator | Drug: Misoprostol (given vaginally)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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Oral misoprostolIn 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. | Drug | Group A |
| Misoprostol (given vaginally)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. | Drug | Group B |
Primary outcome
Induction to Expulsion Interval
Time frame: 48 hours
Induction to expulsion interval is assessed in terms of hours required to expel the conception material.
Efficacy of Oral Versus Vaginal route
Time frame: 24 hours
Efficacy assessed on the basis that no retained conception material in uterus detected on ultrasound after 24 hours of induction
1 secondary outcome
Safety of Oral Misoprostol versus Vaginally administered Misoprostol
Time frame: 48hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oral misoprostol and Misoprostol (given vaginally) in people with Missed Abortion, run by Hamna Khaliq at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Hamna Khaliq, MBBS (+923186333530, hamnakhaliq6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Induction to Expulsion Interval (time frame: 48 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.