Incomplete AbortionNCT01743508
Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians in Uganda
A study testing Misoprostol treatment by midwife in people with Incomplete Abortion, run by Karolinska Institutet at 1 site in Uganda.
Trial summary
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. 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
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 731 participants
- Where
- 1 siteUganda
- Study dates
- Apr 2012to Aug 2017
- 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
- Bleeding
- Contractions during pregnancy
Who cannot join
- Known allergy to misoprostol
- Uterine size more than 12 weeks of gestation
- Suspected ectopic pregnancy
- Unstable hemodynamic status and chock
- Signs of pelvic infection and/or sepsis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians. A Randomized Control Trial in Uganda
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe post abortion care is the lack of providers. So far technical training has been mainly limited to physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care.
Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that there are no significant differences in effectiveness and safety between manual vacuum aspiration and misoprostol treatment of incomplete abortion provided by physicians and midwife.
The involvement of midlevel providers in treatment of incomplete abortion has previously not been systematically evaluated in African health care setting.
Read the detailed description
The project concerns a randomised controlled trial (RCT) aiming to determine whether midwives and physicians can perform medical treatment for incomplete abortion equally safely at primary care level. All patients included are women admitted due to incomplete abortion and will undergo clinical examinations and treatment in accordance with standard procedures (Bluhm et al., 2007, WHO, 2010). A total of 880 women seeking with symptoms of incomplete abortion will be included after giving their informed consent and randomised to diagnosis and care provided by either midwives or physicians. The study will be conducted at the National referral hospital (Mulago in Kampala). A coordinating centre will be established at the Mulago Hospital in Kampala in order to monitor the study. Included in the coordinating team physicians will be involved and have the ultimate responsibility for the medical care provided within the study. The coordinating physicians will evaluate and monitor the midwives and physicians performance to safeguard that the care provided is safe and thus do not put women at risk or the health care provider in any legal inconvenience. All health care providers at the study site included will be provided training that follows the structure of Ipas who have updated standardized training modules within abortion and post abortion care which is used internationally. Dr Charles Kiggundu, one of the principal investigators is currently involved in training for providers at national level in Uganda and thus has adequate competence and experience. The health care provider's attitude and communications skill is one core component in the training. The importance of the study and the study procedure will be another important aspect of the training in order to motivate health care providers involved in the care at the selected study sites.
- Conditions
- Incomplete Abortion
- Being tested
- Misoprostol treatment by midwife
- Keywords
- incomplete abortion, misoprostol treatment, midwife, uganda
- 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 midwifeProcedure or surgery
Misoprostol treatment by midwife
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol by physician | Active comparator | Misoprostol treatment by midwife Receives: Procedure: Misoprostol treatment by midwife |
| Misoprostol by midwife | Experimental | Misoprostol treatment by midwife Receives: Procedure: Misoprostol treatment by midwife |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete abortion
Measured: 14-28 days post treatment
Secondary outcomes (4)
bleeding
Measured: 14-28 days post treatment
pain
Measured: 14-28 days post treatment
women's experiences of the method and care provided
Measured: 14-28 days post treatment
un-scheduled visits
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 posted6 Dec 2012 (estimated)
- Study startApr 2012
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incomplete AbortionStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- 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
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Klingberg-Allvin, Karolinska Institutet
- Investigators
- Elisabeth Faxelid, Professor, Principal investigator, Karolinska InstitutetKristina Gemzell-Danielsson, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743508
- Sponsor's protocol ID
- Sida_2010
- Other IDs
- ZZK9elifax
- Status last verified
- Aug 2017
- First submitted
- 29 Nov 2012
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol Treatment of Incomplete Abortion by Midwives and Physicians. A Randomized Control Trial in Uganda
- ClinicalTrials.gov ID
- NCT01743508
- Acronym / sponsor ID
- Sida_2010
- Conditions
- Incomplete Abortion
- Keywords
- incomplete abortion, misoprostol treatment, midwife, uganda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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.
Uganda is one of the countries with highest fertility rate in the world, 6.7 children per women. It is estimated that 56 percent of all pregnancies are unintended and the contraceptive prevalence rate in Uganda is 23 percent. Unwanted pregnancy is common and induced abortion is illegal. Unsafe abortion is responsible for significant morbidity and mortality among women in Uganda. Almost 40% of admissions to emergency obstetric care units in Uganda due to unsafe abortion is reported and considered high in international comparison. Studies have revealed that trained midlevel providers can deliver safe post abortion care for incomplete abortion and use manual vacuum aspiration. The prostaglandin E1 analogue misoprostol has been shown to be an effective tool in the treatment of incomplete abortions. This option is so far under-used in developing countries, especially outside the larger hospitals and private clinics. One significant limiting factor in providing safe post abortion care is the lack of providers. So far technical training has been mainly limited to physicians. Training of midlevel providers in misoprostol treatment of incomplete abortion will support task shifting in places where doctors are costly and scarce. By evaluating the effectiveness of mid-level providers (midwives); conducting MVA and administering misoprostol treatment of incomplete abortion the project is attempting to contribute to the reduction of maternal mortality and morbidity and safeguard high quality of post-abortion care.
Women with incomplete abortion will be randomly allocated to undergo a clinical assessment and treatment (MVA or misoprostol) either by physician or midwife with safety and efficacy as main outcomes in a RCT carried out in hospital setting in Uganda. Our hypothesis is that there are no significant differences in effectiveness and safety between manual vacuum aspiration and misoprostol treatment of incomplete abortion provided by physicians and midwife.
The involvement of midlevel providers in treatment of incomplete abortion has previously not been systematically evaluated in African health care setting.
Detailed description
The project concerns a randomised controlled trial (RCT) aiming to determine whether midwives and physicians can perform medical treatment for incomplete abortion equally safely at primary care level. All patients included are women admitted due to incomplete abortion and will undergo clinical examinations and treatment in accordance with standard procedures (Bluhm et al., 2007, WHO, 2010). A total of 880 women seeking with symptoms of incomplete abortion will be included after giving their informed consent and randomised to diagnosis and care provided by either midwives or physicians. The study will be conducted at the National referral hospital (Mulago in Kampala). A coordinating centre will be established at the Mulago Hospital in Kampala in order to monitor the study. Included in the coordinating team physicians will be involved and have the ultimate responsibility for the medical care provided within the study. The coordinating physicians will evaluate and monitor the midwives and physicians performance to safeguard that the care provided is safe and thus do not put women at risk or the health care provider in any legal inconvenience. All health care providers at the study site included will be provided training that follows the structure of Ipas who have updated standardized training modules within abortion and post abortion care which is used internationally. Dr Charles Kiggundu, one of the principal investigators is currently involved in training for providers at national level in Uganda and thus has adequate competence and experience. The health care provider's attitude and communications skill is one core component in the training. The importance of the study and the study procedure will be another important aspect of the training in order to motivate health care providers involved in the care at the selected study sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol by physician | Active comparator | Procedure: Misoprostol treatment by midwifeMisoprostol treatment by midwife |
| Misoprostol by midwife | Experimental | Procedure: Misoprostol treatment by midwifeMisoprostol treatment by midwife |
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Bleeding
- Contractions during pregnancy
Key exclusion criteria (5 listed)
- Known allergy to misoprostol
- Uterine size more than 12 weeks of gestation
- Suspected ectopic pregnancy
- Unstable hemodynamic status and chock
- Signs of pelvic infection and/or sepsis
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 midwifeMisoprostol treatment by midwife | Procedure or surgery | Misoprostol by midwife, Misoprostol by physician |
Primary outcome
complete abortion
Time frame: 14-28 days post treatment
4 secondary outcomes
bleeding
Time frame: 14-28 days post treatment
pain
Time frame: 14-28 days post treatment
women's experiences of the method and care provided
Time frame: 14-28 days post treatment
un-scheduled visits
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 18 Aug 2017.
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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.
Elisabeth Faxelid, Professor principal investigator
Karolinska Institutet
Kristina Gemzell-Danielsson, Professor principal investigator
Karolinska Institutet
1 site 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 in people with Incomplete Abortion, run by Karolinska Institutet at 1 site 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 2 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 18 Aug 2017. 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 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: 14-28 days post treatment). 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 18 Aug 2017.