Postpartum HaemorrhageNCT01485562
Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
A study testing Misoprostol in people with Postpartum Haemorrhage, run by Gynuity Health Projects at 1 site in Pakistan.
Trial summary
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Haemorrhage
- 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
- 84 participants
- Where
- 1 sitePakistan
- Study dates
- May 2012to Dec 2014
- 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 who deliver at home with a study TBA present.
- Women must be willing and able to provide informed consent
- Women must agree to participate in a follow up interview
- Women must agree to have pre and post-partum haemoglobin taken
Who cannot join
- If the woman does not meet any of the above outlined inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.
Read the detailed description
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.
The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.
- Conditions
- Postpartum Haemorrhage
- Being tested
- Misoprostol, placebo
- Keywords
- postpartum haemorrhage, misoprostol, treatment, prophylaxis, home births
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Gymiso
4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
placeboOther
Also called Gymiso
4 tablets, administered sublingually if the woman experiences a PPH
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Active comparator | women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually) Receives: Drug: Misoprostol |
| placebo | Placebo comparator | women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemoglobin concentration (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.
Measured: 3-5 days after delivery
Secondary outcomes (4)
Number of participants who experience side effects
number of women who experienced side effects and the severity of the side effects as rated on a scale, additional care provided
Measured: immediately after delivery; 3-5 days post delivery
number of participants who received additional interventions
number of participants who received care by as skilled provider and the type of care provided
Measured: immediately after delivery; 3-5 days post delivery
number of women who found misoprostol treatment to be acceptable
women will be asked to rate their acceptability with the treatment using a scale
Measured: immediately after delivery; 3-5 days post delivery
number of participants who experience severe adverse events
serious adverse are defined as uterine rupture, hysterectomy, hospitalization, maternal deaths, and neonatal deaths.
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 posted5 Dec 2011 (estimated)
- Study startMay 2012
- Primary completionDec 2014
- Study completionDec 2014
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 HaemorrhageStudies 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
- 84 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
- Zafar Khan, Principal investigator, Aga Khan Health ServicesNadeem Zuberi, Study director, Aga Khan UniversityGijs Walraven, Study director, Secretariat of His Highness the Aga Khan, AiglemontAyisha Diop, Study director, Gynuity Health ProjectsDina Abbas, Study director, Gynuity Health Projects
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01485562
- Sponsor's protocol ID
- 2.4.15
- Status last verified
- Mar 2016
- First submitted
- 1 Dec 2011
- Last updated
- 10 Mar 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, Jehan N, Diop A, Durocher J, Byrne ME, Zuberi N, Ahmed Z, Walraven G, Winikoff B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019 Mar;144(3):290-296. doi: 10.1002/ijgo.12756. Epub 2019 Jan 24.
PubMed 30582753
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postpartum Haemorrhage (PPH) Using Misoprostol in Home Births
- ClinicalTrials.gov ID
- NCT01485562
- Acronym / sponsor ID
- 2.4.15
- Conditions
- Postpartum Haemorrhage
- Keywords
- postpartum haemorrhage, misoprostol, treatment, prophylaxis, home births
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Gynuity Health ProjectsUniversity, hospital or other
- Collaborators
- Aga Khan Health Services
- Study start
- May 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 5 Dec 2011 (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.
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan.
Detailed description
A double-blind individual randomized controlled study of misoprostol vs. placebo for treatment in homebirths in the Chitral district, in the Khyber Pakhtunkhwa province in Pakistan. The purpose of the study is to assess the overall clinical and programmatic effectiveness of Traditional Birth Attendants (TBAs) administering 800 mcg sublingual misoprostol to treat Postpartum Haemorrhage (PPH) at the community level.
The study will recruit pregnant women who deliver at home. All women enrolled in the study will receive misoprostol for prevention (600 mcg oral dose). Women diagnosed with PPH will be randomized to receive either a) standard care + 800 mcg sublingual misoprostol (four 200 mcg tablets) or b) standard care + four placebo tablets resembling misoprostol. In this setting, standard care is uterine massage and/or compression and referral to the nearest health facility or attendance by the Lady Health Visitor/ Community Health Nurse.
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: Misoprostolwomen who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually) |
| placebo | Placebo comparator | Other: placebowomen who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Women who deliver at home with a study TBA present.
- Women must be willing and able to provide informed consent
- Women must agree to participate in a follow up interview
- Women must agree to have pre and post-partum haemoglobin taken
Key exclusion criteria (1 listed)
- If the woman does not meet any of the above outlined 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 |
|---|---|---|
| MisoprostolAlso: Gymiso4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth | Drug | Misoprostol |
| placeboAlso: Gymiso4 tablets, administered sublingually if the woman experiences a PPH | Other | placebo |
Primary outcome
Haemoglobin concentration (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.
4 secondary outcomes
Number of participants who experience side effects
Time frame: immediately after delivery; 3-5 days post delivery
number of participants who received additional interventions
Time frame: immediately after delivery; 3-5 days post delivery
number of women who found misoprostol treatment to be acceptable
Time frame: immediately after delivery; 3-5 days post delivery
number of participants who experience severe adverse events
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 10 Mar 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 30582753Abbas DF, Jehan N, Diop A, Durocher J, Byrne ME, Zuberi N, Ahmed Z, Walraven G, Winikoff B. Using misoprostol to treat postpartum hemorrhage in home deliveries attended by traditional birth attendants. Int J Gynaecol Obstet. 2019 Mar;144(3):290-296. doi: 10.1002/ijgo.12756. Epub 2019 Jan 24.
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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.
Zafar Khan principal investigator
Aga Khan Health Services
Nadeem Zuberi study director
Aga Khan University
Gijs Walraven study director
Secretariat of His Highness the Aga Khan, Aiglemont
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 Haemorrhage, run by Gynuity Health Projects 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 4 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 10 Mar 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 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. 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?
Haemoglobin concentration (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 NCT01485562, 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 10 Mar 2016.