Postpartum Hemorrhage (PPH)NCT01508429
Misoprostol for Treatment of Postpartum Haemorrhage (PPH) in Home Births
A study testing Misoprostol in people with Postpartum Hemorrhage (PPH), run by Gynuity Health Projects at 1 site in Afghanistan.
Trial summary
Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage (PPH)
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteAfghanistan
- Study dates
- Jul 2012to Feb 2016
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Women must be pregnant
- Must be able to provide informed consent
- Must agree to have a community health worker present at the time of delivery
- Must agree to participate in a follow up interview by the study midwife
- Must agree to have pre and postpartum haemoglobin taken
Who cannot join
- Women who do not meet the inclusion criteria
Trial locations and contacts
1 site in 1 country.
Afghanistan1 site
Home delivery setting
Darwaz, Ishkashim, Shugnan, Wakhan Districts, Badakshan Province
About this study
Official title: Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.
A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.
Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.
- Conditions
- Postpartum Hemorrhage (PPH)
- Being tested
- placebo, Misoprostol
- Keywords
- Postpartum hemorrhage, PPH, misoprostol, home deliveries
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboOther
4 placebo tablets (resembling misoprostol) administered sublingually
MisoprostolDrug
800mcg misoprostol (4 200mcg tablets administered sublingually)
| Study group | Role | What they receive |
|---|---|---|
| misoprostol | Active comparator | 800mcg misoprostol (four tablets of 200 mcg administered sublingually) Receives: Drug: Misoprostol |
| placebo | Placebo comparator | 4 placebo tablets (resembling misoprostol) administered sublingually Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hb of greater than or equal to 2 g/dl from pre- to post-delivery
The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.
Measured: 3-5 days after delivery
Secondary outcomes (3)
Side effects
Observed side effects: perceived severity, additional care provided Any serious adverse outcomes including uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
Measured: immediately after delivery; 3-5 days post delivery
additional interventions
Additional interventions and additional care provided to the woman, # of referrals and transfers
Measured: immediately after delivery; 3-5 days post delivery
Acceptability
Acceptability and management of side effects, acceptablity of taking the drugs
Measured: immediately after delivery; 3-5 days post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2012 (estimated)
- Study startJul 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postpartum Hemorrhage (PPH)Studies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gynuity Health Projects
- Sponsor type
- University, hospital or other
- Collaborators
- Aga Khan Health Services
- Responsible party
- Sponsor
- Investigators
- Shafiq Mirzazada, Principal investigator, Aga Khan Health ServicesGijs Walraven, Study director, Secretariat of His Highness the Aga Khan, AiglemontDina Abbas, Study director, Gynuity Health ProjectsJill Durocher, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508429
- Sponsor's protocol ID
- 2.4.14
- Status last verified
- Jul 2016
- First submitted
- 1 Dec 2011
- Last updated
- 11 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
PubMed 33232518Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.
PubMed 32503556
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Misoprostol for the Treatment of Postpartum Haemorrhage (PPH) Following Self- Administration of Misoprostol Prophylaxis in Home Deliveries.
- ClinicalTrials.gov ID
- NCT01508429
- Acronym / sponsor ID
- 2.4.14
- Conditions
- Postpartum Hemorrhage (PPH)
- Keywords
- Postpartum hemorrhage, PPH, misoprostol, home deliveries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Aga Khan Health Services
- Study start
- Jul 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 12 Jan 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.
Misoprostol, a prostaglandin E1 that induces uterine contractions, has been proposed as a low cost, easy-to-use option for prevention and treatment of Postpartum Haemorrhage (PPH), especially in settings where injectable uterotonics are not yet available or feasible to use.
A double-blinded individual randomized controlled study of misoprostol versus placebo in home deliveries in four districts in the Badakshan Province in Afghanistan. The study will recruit pregnant women who are likely to deliver at home. All women enrolled in the study will receive 600 mcg misoprostol to be self-administered as prophylaxis for PPH after delivery of their baby (ies) and before delivery of the placenta.
Women who experience a PPH will be randomized to receive either: a) standard of care + 800 mcg misoprostol (four 200 mcg tablets) or b) standard of care + four placebo tablets resembling misoprostol. In this setting, standard of care is referral.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| misoprostol | Active comparator | Drug: Misoprostol800mcg misoprostol (four tablets of 200 mcg administered sublingually) |
| placebo | Placebo comparator | Other: placebo4 placebo tablets (resembling misoprostol) administered sublingually |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Women must be pregnant
- Must be able to provide informed consent
- Must agree to have a community health worker present at the time of delivery
- Must agree to participate in a follow up interview by the study midwife
- Must agree to have pre and postpartum haemoglobin taken
Key exclusion criteria (1 listed)
- Women who do not meet the inclusion criteria
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 |
|---|---|---|
| placebo4 placebo tablets (resembling misoprostol) administered sublingually | Other | placebo |
| Misoprostol800mcg misoprostol (4 200mcg tablets administered sublingually) | Drug | misoprostol |
Primary outcome
Hb of greater than or equal to 2 g/dl from pre- to post-delivery
Time frame: 3-5 days after delivery
The primary outcome will measure the proportion of women who experience a drop in their haemoglobin concentration (Hb) of greater than 2 g/dl from pre- to post-delivery. The outcome will be compared between the two treatment groups.
3 secondary outcomes
Side effects
Time frame: immediately after delivery; 3-5 days post delivery
additional interventions
Time frame: immediately after delivery; 3-5 days post delivery
Acceptability
Time frame: immediately after delivery; 3-5 days post delivery
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 Jul 2016.
- Derived from this study: PubMed 33232518Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.
- Derived from this study: PubMed 32503556Abbas DF, Mirzazada S, Durocher J, Pamiri S, Byrne ME, Winikoff B. Testing a home-based model of care using misoprostol for prevention and treatment of postpartum hemorrhage: results from a randomized placebo-controlled trial conducted in Badakhshan province, Afghanistan. Reprod Health. 2020 Jun 5;17(1):88. doi: 10.1186/s12978-020-00933-8.
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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.
Shafiq Mirzazada principal investigator
Aga Khan Health Services
Gijs Walraven study director
Secretariat of His Highness the Aga Khan, Aiglemont
Dina Abbas study director
Gynuity Health Projects
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 in people with Postpartum Hemorrhage (PPH), run by Gynuity Health Projects at 1 site in Afghanistan.
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 5 inclusion and 1 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 Jul 2016. 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 Afghanistan. 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. Some participants in this study may receive a placebo. 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?
Hb of greater than or equal to 2 g/dl from pre- to post-delivery (time frame: 3-5 days after delivery). 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 NCT01508429, which also lists 2 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 Jul 2016.