Incomplete AbortionNCT03622073
Misoprostol Treatment of Mid Trimester Incomplete Abortion by Midwives and Doctors in Uganda.
A study testing Misoprostol treatment by Midwife and Misoprostol treatment by Doctor in people with Incomplete Abortion, run by Makerere University at 14 sites in Uganda.
Trial summary
It is estimated that 47,000 women die every year due to consequences of unsafe abortion globally. The majority of pregnancy related deaths occur in low income countries where induced abortion is restricted, unmet need for contraception is high, and women's status is low. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Incomplete Abortion
- What is being tested?
- Misoprostol treatment by Midwife and Misoprostol treatment by Doctor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,191 participants
- Where
- 14 sitesUganda
- Study dates
- 14 Aug 2018to 16 Dec 2021
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vaginal bleeding
- With or without contractions with a uterine size > 12 weeks to < 18 weeks
- History of partial expulsion
- Open cervical os.
Who cannot join
- Known allergy to misoprostol,
- Unstable hemodynamic status (systolic blood pressure < 90mmHg) and shock
- Signs of pelvic infection and/or sepsis
- Previous caesarean delivery/uterine scar
- Suspected extra uterine pregnancy.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Uganda14 sites
Entebbe Hospital
Entebbe
Gombe Hospital
Gombe
Kawempe Hospital
Kampala
Kayunga Hospital
Kayunga, 256
Kawolo Hospital
Lugazi, 256
Luwero HC IV
Luwero
Masaka Hospital
Masaka
Mityana Hospital
Mityana
Mpigi HC IV
Mpigi
Kiganda HC IV
Mubende, 256
Mukono HC IV
Mukono
Nakaseke Hospital
Nakaseke
Kasangati HC IV
Wakiso, 256
Wakiso HC IV
Wakiso, 256
About this study
Official title: Safety, Effectiveness and Acceptability of Misoprostol When Administered by Midwives Versus Physicians for Management of Incomplete Mid Trimester Abortion in Uganda: a Randomized Controlled Equivalence Trial.
It is estimated that 47,000 women die every year due to consequences of unsafe abortion globally. The majority of pregnancy related deaths occur in low income countries where induced abortion is restricted, unmet need for contraception is high, and women's status is low. Uganda has a high total fertility rate of 5.4 children per woman, low contraceptive prevalence rate of 39%, and more than half of these pregnancies are unintended. Induced abortion is controversial and restricted in Uganda and legally permitted only to save a woman's life. As a result, women often resort to unsafe abortion- that's either performed by a person lacking the necessary skills or in an environment that does not conform to minimal medical standards. Of the estimated 314,304 women who undergo unsafe abortions each year in Uganda, about 41% receive treatment for complications. This equates to an annual rate of 12 per 1,000 women aged 15-49 years being hospitalized for induced abortion complications, which is considered high in international comparison. In Uganda, outside the larger hospitals and private settings, access to safe post abortion care and surgical facilities are scarce. Studies have showed that trained midwives can deliver safe, effective and acceptable post abortion care using misoprostol in the first trimester. Currently in Uganda, treatment of second trimester incomplete abortion is restricted to physicians. This study will provide evidence on whether treatment for incomplete abortion using misoprostol by mid-level providers can be extended to the early second trimester period. The investigators hypothesize that misoprostol treatment for incomplete second trimester abortion provided by midwives is equivalent to that of physicians requiring no further surgical intervention. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment with misoprostol either by physician or midwife with safety and effectiveness as main outcomes in the RCT carried out in hospital and high volume health centres in Central Uganda.
Read the detailed description
This randomized controlled equivalence trial (RCT) implemented at eight hospitals and Health centres in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size >12 weeks up to 18 weeks. Following informed consent, each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or physician (control arm); receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve a complete abortion within 24 hours will undergo a surgical method of uterine evacuation. Pre-discharge information on danger signs, contraceptive counselling and provision will be done with follow up 14 days later to assess secondary outcomes and acceptability. Analyses will be by Intention-to-Treat (ITT). Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant.
- Conditions
- Incomplete Abortion
- Being tested
- Misoprostol treatment by Midwife, Misoprostol treatment by Doctor
- Keywords
- Post abortion care, Misoprostol, Second trimester
- Medical subject headings
- Abortion, Incomplete
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol treatment by MidwifeOther
Medical management of incomplete abortion
Misoprostol treatment by DoctorOther
Medical management of incomplete abortion
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol treatment by Midwife | Experimental | Administration of misoprostol by the midwife and assessment for the primary outcome. Receives: Other: Misoprostol treatment by Midwife |
| Misoprostol treatment by Doctor | Active comparator | Administration of misoprostol by the doctor and assessment for the primary outcome. Receives: Other: Misoprostol treatment by Doctor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete abortion
Number of participants who will have expelled all the products of conception as evidenced by cessation of abdominal cramps, vaginal bleeding and closed cervical os.
Measured: 24 hours from treatment initiation
Secondary outcomes (4)
Excessive vaginal bleeding
Participant reporting use of more than 3 pads in an hour.
Measured: 24 hours from treatment initiation
Abdominal Pain
Pain will be defined as discomfort experienced in the lower abdomen using a visual analogue scale with a minimum score of zero representing no pain and a maximum score of 10 representing most pain. A higher score represents a worse outcome.
Measured: 24 hours from treatment initiation
Unscheduled visits
Participant presenting at the study site when not expected
Measured: 14-28 days post treatment
Women's acceptability of the post abortion care provider
Acceptability will be positive reporting of treatment experience, recommendation of method to a friend or reuse of same method.
Measured: 14-28 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start14 Aug 2018
- Primary completion16 Nov 2021
- Study completion16 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Incomplete 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 1,191 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makerere University
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, London School of Hygiene and Tropical Medicine
- Responsible party
- Sponsor
- Investigators
- Kristina G Danielsson, PhD, Principal investigator, Karolinska InstitutetJosaphat Byamugisha, PhD, Principal investigator, Makerere UniversitySusan Atuhairwe, MD, Principal investigator, Makerere University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03622073
- Sponsor's protocol ID
- REC REF 2017-016
- Status last verified
- Mar 2022
- First submitted
- 19 Jun 2018
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be available on request for systematic reviews. The particular data shared will depend on the request.
Publications
Faundes A. Strategies for the prevention of unsafe abortion. Int J Gynaecol Obstet. 2012 Oct;119 Suppl 1:S68-71. doi: 10.1016/j.ijgo.2012.03.021. Epub 2012 Aug 9.
PubMed 22883917Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, Rossier C, Gerdts C, Tuncalp O, Johnson BR Jr, Johnston HB, Alkema L. Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends. Lancet. 2016 Jul 16;388(10041):258-67. doi: 10.1016/S0140-6736(16)30380-4. Epub 2016 May 11.
PubMed 27179755Uganda Bureau of Statistcs (UBOS) and ICF. 2017. Uganda Demographic and Health Survey 2016: Key Indicators Report. Kampala, Uganda: UBOS, and Rockville, Maryland, USA: UBOS and ICF.
Hussain R. Unintended pregnancy and abortion in Uganda. Issues Brief (Alan Guttmacher Inst). 2013 Jan;(2):1-8.
PubMed 23550324Prada E, Atuyambe LM, Blades NM, Bukenya JN, Orach CG, Bankole A. Incidence of Induced Abortion in Uganda, 2013: New Estimates Since 2003. PLoS One. 2016 Nov 1;11(11):e0165812. doi: 10.1371/journal.pone.0165812. eCollection 2016.
PubMed 27802338Mark AG, Edelman A, Borgatta L. Second-trimester postabortion care for ruptured membranes, fetal demise, and incomplete abortion. Int J Gynaecol Obstet. 2015 May;129(2):98-103. doi: 10.1016/j.ijgo.2014.11.011. Epub 2015 Jan 19.
PubMed 25660084Klingberg-Allvin M, Cleeve A, Atuhairwe S, Tumwesigye NM, Faxelid E, Byamugisha J, Gemzell-Danielsson K. Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda: a randomised controlled equivalence trial. Lancet. 2015 Jun 13;385(9985):2392-8. doi: 10.1016/S0140-6736(14)61935-8. Epub 2015 Mar 27.
PubMed 25817472Cleeve A, Byamugisha J, Gemzell-Danielsson K, Mbona Tumwesigye N, Atuhairwe S, Faxelid E, Klingberg-Allvin M. Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda. PLoS One. 2016 Feb 12;11(2):e0149172. doi: 10.1371/journal.pone.0149172. eCollection 2016.
PubMed 26872219Moran M, Ortega J, Hodoglugil NN. Osur et al.'s Implementation of misoprostol for postabortion care in Kenya and Uganda: a qualitative evaluation. Glob Health Action. 2012 Jul 18;6:21786. doi: 10.3402/gha.v6i0.21786. No abstract available.
PubMed 23870184Pongsatha S, Tongsong T. Randomized controlled trial comparing efficacy between a vaginal misoprostol loading and non-loading dose regimen for second-trimester pregnancy termination. J Obstet Gynaecol Res. 2014 Jan;40(1):155-60. doi: 10.1111/jog.12147. Epub 2013 Sep 5.
PubMed 24033985Dawson AJ, Buchan J, Duffield C, Homer CS, Wijewardena K. Task shifting and sharing in maternal and reproductive health in low-income countries: a narrative synthesis of current evidence. Health Policy Plan. 2014 May;29(3):396-408. doi: 10.1093/heapol/czt026. Epub 2013 May 8.
PubMed 23656700Nabudere H, Asiimwe D, Mijumbi R. Task shifting in maternal and child health care: an evidence brief for Uganda. Int J Technol Assess Health Care. 2011 Apr;27(2):173-9. doi: 10.1017/S0266462311000055. Epub 2011 Mar 30.
PubMed 21450128Atuhairwe S, Hanson C, Atuyambe L, Byamugisha J, Tumwesigye NM, Ssenyonga R, Gemzell-Danielsson K. Evaluating women's acceptability of treatment of incomplete second trimester abortion using misoprostol provided by midwives compared with physicians: a mixed methods study. BMC Womens Health. 2022 Nov 5;22(1):434. doi: 10.1186/s12905-022-02027-y.
PubMed 36335344Atuhairwe S, Byamugisha J, Kakaire O, Hanson C, Cleeve A, Klingberg-Allvin M, Tumwesigye NM, Gemzell-Danielsson K. Comparison of the effectiveness and safety of treatment of incomplete second trimester abortion with misoprostol provided by midwives and physicians: a randomised, controlled, equivalence trial in Uganda. Lancet Glob Health. 2022 Oct;10(10):e1505-e1513. doi: 10.1016/S2214-109X(22)00312-6. Epub 2022 Aug 26.
PubMed 36030801Atuhairwe S, Byamugisha J, Klingberg-Allvin M, Cleeve A, Hanson C, Tumwesigye NM, Kakaire O, Danielsson KG. Evaluating the safety, effectiveness and acceptability of treatment of incomplete second-trimester abortion using misoprostol provided by midwives compared with physicians: study protocol for a randomized controlled equivalence trial. Trials. 2019 Jun 21;20(1):376. doi: 10.1186/s13063-019-3490-5.
PubMed 31227019
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety, Effectiveness and Acceptability of Misoprostol When Administered by Midwives Versus Physicians for Management of Incomplete Mid Trimester Abortion in Uganda: a Randomized Controlled Equivalence Trial.
- ClinicalTrials.gov ID
- NCT03622073
- Acronym / sponsor ID
- REC REF 2017-016
- Conditions
- Incomplete Abortion
- Keywords
- Post abortion care, Misoprostol, Second trimester
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,191 participants (actual)
- Lead sponsor
- Makerere UniversityUniversity, hospital or other
- Collaborators
- Karolinska Institutet, London School of Hygiene and Tropical Medicine
- Study start
- 14 Aug 2018 (actual)
- Primary completion
- 16 Nov 2021 (actual)
- Study completion
- 16 Dec 2021 (actual)
- First posted
- 9 Aug 2018 (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.
It is estimated that 47,000 women die every year due to consequences of unsafe abortion globally. The majority of pregnancy related deaths occur in low income countries where induced abortion is restricted, unmet need for contraception is high, and women's status is low. Uganda has a high total fertility rate of 5.4 children per woman, low contraceptive prevalence rate of 39%, and more than half of these pregnancies are unintended. Induced abortion is controversial and restricted in Uganda and legally permitted only to save a woman's life. As a result, women often resort to unsafe abortion- that's either performed by a person lacking the necessary skills or in an environment that does not conform to minimal medical standards. Of the estimated 314,304 women who undergo unsafe abortions each year in Uganda, about 41% receive treatment for complications. This equates to an annual rate of 12 per 1,000 women aged 15-49 years being hospitalized for induced abortion complications, which is considered high in international comparison. In Uganda, outside the larger hospitals and private settings, access to safe post abortion care and surgical facilities are scarce. Studies have showed that trained midwives can deliver safe, effective and acceptable post abortion care using misoprostol in the first trimester. Currently in Uganda, treatment of second trimester incomplete abortion is restricted to physicians. This study will provide evidence on whether treatment for incomplete abortion using misoprostol by mid-level providers can be extended to the early second trimester period. The investigators hypothesize that misoprostol treatment for incomplete second trimester abortion provided by midwives is equivalent to that of physicians requiring no further surgical intervention. Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment with misoprostol either by physician or midwife with safety and effectiveness as main outcomes in the RCT carried out in hospital and high volume health centres in Central Uganda.
Detailed description
This randomized controlled equivalence trial (RCT) implemented at eight hospitals and Health centres in Central Uganda will include 1192 eligible women with incomplete abortion of uterine size >12 weeks up to 18 weeks. Following informed consent, each participant will be randomly assigned to undergo a clinical assessment and treatment by either a midwife (intervention arm) or physician (control arm); receive 400mcg of misoprostol administered sublingually 3 hourly up to 5 doses within 24 hours at the health facility until a complete abortion is confirmed. Women who do not achieve a complete abortion within 24 hours will undergo a surgical method of uterine evacuation. Pre-discharge information on danger signs, contraceptive counselling and provision will be done with follow up 14 days later to assess secondary outcomes and acceptability. Analyses will be by Intention-to-Treat (ITT). Background characteristics and outcomes will be presented using descriptive statistics. Differences between groups will be analyzed using risk difference (95% CI) and equivalence established if it lies between the pre-defined range of -5% to +5%. Chi-square test will be used for comparison of outcome and t test used to compare mean values. P-values equal to or lower than 0.05 will be considered statistically significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol treatment by Midwife | Experimental | Other: Misoprostol treatment by MidwifeAdministration of misoprostol by the midwife and assessment for the primary outcome. |
| Misoprostol treatment by Doctor | Active comparator | Other: Misoprostol treatment by DoctorAdministration of misoprostol by the doctor and assessment for the primary outcome. |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Vaginal bleeding
- With or without contractions with a uterine size > 12 weeks to < 18 weeks
- History of partial expulsion
- Open cervical os.
Key exclusion criteria (5 listed)
- Known allergy to misoprostol,
- Unstable hemodynamic status (systolic blood pressure < 90mmHg) and shock
- Signs of pelvic infection and/or sepsis
- Previous caesarean delivery/uterine scar
- Suspected extra uterine pregnancy.
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 |
|---|---|---|
| Misoprostol treatment by MidwifeMedical management of incomplete abortion | Other | Misoprostol treatment by Midwife |
| Misoprostol treatment by DoctorMedical management of incomplete abortion | Other | Misoprostol treatment by Doctor |
Primary outcome
Complete abortion
Time frame: 24 hours from treatment initiation
Number of participants who will have expelled all the products of conception as evidenced by cessation of abdominal cramps, vaginal bleeding and closed cervical os.
4 secondary outcomes
Excessive vaginal bleeding
Time frame: 24 hours from treatment initiation
Abdominal Pain
Time frame: 24 hours from treatment initiation
Unscheduled visits
Time frame: 14-28 days post treatment
Women's acceptability of the post abortion care provider
Time frame: 14-28 days post treatment
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 11 Mar 2022.
- Background: PubMed 22883917Faundes A. Strategies for the prevention of unsafe abortion. Int J Gynaecol Obstet. 2012 Oct;119 Suppl 1:S68-71. doi: 10.1016/j.ijgo.2012.03.021. Epub 2012 Aug 9.
- Background: PubMed 27179755Sedgh G, Bearak J, Singh S, Bankole A, Popinchalk A, Ganatra B, Rossier C, Gerdts C, Tuncalp O, Johnson BR Jr, Johnston HB, Alkema L. Abortion incidence between 1990 and 2014: global, regional, and subregional levels and trends. Lancet. 2016 Jul 16;388(10041):258-67. doi: 10.1016/S0140-6736(16)30380-4. Epub 2016 May 11.
- BackgroundUganda Bureau of Statistcs (UBOS) and ICF. 2017. Uganda Demographic and Health Survey 2016: Key Indicators Report. Kampala, Uganda: UBOS, and Rockville, Maryland, USA: UBOS and ICF.
- Background: PubMed 23550324Hussain R. Unintended pregnancy and abortion in Uganda. Issues Brief (Alan Guttmacher Inst). 2013 Jan;(2):1-8.
- Background: PubMed 27802338Prada E, Atuyambe LM, Blades NM, Bukenya JN, Orach CG, Bankole A. Incidence of Induced Abortion in Uganda, 2013: New Estimates Since 2003. PLoS One. 2016 Nov 1;11(11):e0165812. doi: 10.1371/journal.pone.0165812. eCollection 2016.
- Background: PubMed 25660084Mark AG, Edelman A, Borgatta L. Second-trimester postabortion care for ruptured membranes, fetal demise, and incomplete abortion. Int J Gynaecol Obstet. 2015 May;129(2):98-103. doi: 10.1016/j.ijgo.2014.11.011. Epub 2015 Jan 19.
- Background: PubMed 25817472Klingberg-Allvin M, Cleeve A, Atuhairwe S, Tumwesigye NM, Faxelid E, Byamugisha J, Gemzell-Danielsson K. Comparison of treatment of incomplete abortion with misoprostol by physicians and midwives at district level in Uganda: a randomised controlled equivalence trial. Lancet. 2015 Jun 13;385(9985):2392-8. doi: 10.1016/S0140-6736(14)61935-8. Epub 2015 Mar 27.
- Background: PubMed 26872219Cleeve A, Byamugisha J, Gemzell-Danielsson K, Mbona Tumwesigye N, Atuhairwe S, Faxelid E, Klingberg-Allvin M. Women's Acceptability of Misoprostol Treatment for Incomplete Abortion by Midwives and Physicians - Secondary Outcome Analysis from a Randomized Controlled Equivalence Trial at District Level in Uganda. PLoS One. 2016 Feb 12;11(2):e0149172. doi: 10.1371/journal.pone.0149172. eCollection 2016.
- Background: PubMed 23870184Moran M, Ortega J, Hodoglugil NN. Osur et al.'s Implementation of misoprostol for postabortion care in Kenya and Uganda: a qualitative evaluation. Glob Health Action. 2012 Jul 18;6:21786. doi: 10.3402/gha.v6i0.21786. No abstract available.
- Background: PubMed 24033985Pongsatha S, Tongsong T. Randomized controlled trial comparing efficacy between a vaginal misoprostol loading and non-loading dose regimen for second-trimester pregnancy termination. J Obstet Gynaecol Res. 2014 Jan;40(1):155-60. doi: 10.1111/jog.12147. Epub 2013 Sep 5.
- Background: PubMed 23656700Dawson AJ, Buchan J, Duffield C, Homer CS, Wijewardena K. Task shifting and sharing in maternal and reproductive health in low-income countries: a narrative synthesis of current evidence. Health Policy Plan. 2014 May;29(3):396-408. doi: 10.1093/heapol/czt026. Epub 2013 May 8.
- Background: PubMed 21450128Nabudere H, Asiimwe D, Mijumbi R. Task shifting in maternal and child health care: an evidence brief for Uganda. Int J Technol Assess Health Care. 2011 Apr;27(2):173-9. doi: 10.1017/S0266462311000055. Epub 2011 Mar 30.
- Individual participant dataSharing planned: Yes. Deidentified data will be available on request for systematic reviews. The particular data shared will depend on the 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.
Kristina G Danielsson, PhD principal investigator
Karolinska Institutet
Josaphat Byamugisha, PhD principal investigator
Makerere University
Susan Atuhairwe, MD principal investigator
Makerere University
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol treatment by Midwife and Misoprostol treatment by Doctor in people with Incomplete Abortion, run by Makerere University at 14 sites in Uganda.
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 4 inclusion and 5 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 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Uganda. 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?
Complete abortion (time frame: 24 hours from treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03622073, which also lists 15 linked publications.
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 11 Mar 2022.