Termination of PregnancyNCT04602052
Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia
A study testing Dilation and evacuation in people with Termination of Pregnancy, run by St. Paul's Hospital Millennium Medical College, Ethiopia at 1 site in Ethiopia.
Trial summary
The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Termination of Pregnancy
- What is being tested?
- Dilation and evacuation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 279 participants
- Where
- 1 siteEthiopia
- Study dates
- 1 Nov 2018to 31 Oct 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age between 13 - 20 weeks confirmed with ultrasound,
- Age at or more than18 years,
- Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.
Who cannot join
- Inability to give consent
- complicated abortion (missed abortion, septic abortion)
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Saint Paul's Hospital Millennium Medical College
Addis Ababa, 1271
About this study
Official title: Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.
The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion
Read the detailed description
All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.
- Conditions
- Termination of Pregnancy
- Being tested
- Dilation and evacuation
- Keywords
- Dilation and evacuation, Second Trimester, Medical abortion, Ethiopia
- Medical subject headings
- Dilatation, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dilation and evacuationProcedure or surgery
Also called Medical abortion
Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique
| Study group | Role | What they receive |
|---|---|---|
| Medical arm | Active comparator | Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Receives: Procedure: Dilation and evacuation |
| Surgical arm | Experimental | Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion. Receives: Procedure: Dilation and evacuation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite complication rate
Presence of one of the following complications: bleeding requiring observation, genital tract lacerations requiring repair, need for additional intervention to complete the abortion procedure, and one or more symptoms of pelvic infection
Measured: During the abortion procedure and within 2 weeks post procedure
Secondary outcomes (1)
Other serious maternal complications
Continued bleeding for more than two weeks, additional major surgery (laparotomy), and death.
Measured: During the abortion procedure and within 2 weeks post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2020
- Study start1 Nov 2018
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Termination of PregnancyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Paul's Hospital Millennium Medical College, Ethiopia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tesfaye H. Tufa, MD, St. Paul's Hospital Millennium Medical College, Ethiopia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04602052
- Sponsor's protocol ID
- StPaulsHMM
- Status last verified
- Oct 2020
- First submitted
- 14 Oct 2020
- Last updated
- 26 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Information can be shared up on request
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Versus Medical Termination of Pregnancy Between 13-20 Weeks of Gestation in Ethiopia: A Quasi-experimental Study.
- ClinicalTrials.gov ID
- NCT04602052
- Acronym / sponsor ID
- StPaulsHMM
- Conditions
- Termination of Pregnancy
- Keywords
- Dilation and evacuation, Second Trimester, Medical abortion, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- St. Paul's Hospital Millennium Medical College, EthiopiaUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 26 Oct 2020 (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.
The purpose of the study is to determine the safety and effectiveness of dilation and evacuation for surgical abortion as compared to medical abortion
Detailed description
All patients with a gestational age between 13-20 weeks are fully counseled on the risks and benefits and given the option of medical or surgical abortion. Those who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. Those who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medical arm | Active comparator | Procedure: Dilation and evacuationThose who choose medical abortion receive mifepristone 200 mg on day 1 and are appointed to return to SPHMMC 24-48 hours later for admission and misoprostol administration. |
| Surgical arm | Experimental | Procedure: Dilation and evacuationThose who chose surgical abortion are given mifepristone 200 mg with or without laminaria and appointed to return the next day for surgical abortion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Gestational age between 13 - 20 weeks confirmed with ultrasound,
- Age at or more than18 years,
- Having a working phone and willingness to be contacted for a follow-up questionnaire 2 weeks after the procedure.
Key exclusion criteria (2 listed)
- Inability to give consent
- complicated abortion (missed abortion, septic abortion)
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 |
|---|---|---|
| Dilation and evacuationAlso: Medical abortionAbortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique | Procedure or surgery | Medical arm, Surgical arm |
Primary outcome
Composite complication rate
Time frame: During the abortion procedure and within 2 weeks post procedure
Presence of one of the following complications: bleeding requiring observation, genital tract lacerations requiring repair, need for additional intervention to complete the abortion procedure, and one or more symptoms of pelvic infection
1 secondary outcome
Other serious maternal complications
Time frame: During the abortion procedure and within 2 weeks post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Individual participant dataSharing planned: Yes. Information can be shared up on request
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dilation and evacuation in people with Termination of Pregnancy, run by St. Paul's Hospital Millennium Medical College, Ethiopia at 1 site in Ethiopia.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 26 Oct 2020. 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 Ethiopia. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite complication rate (time frame: During the abortion procedure and within 2 weeks post procedure). 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 26 Oct 2020.