NCT01485562

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 1, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
5 months until next milestone

Study Start

First participant enrolled

May 1, 2012

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

March 10, 2016

Status Verified

March 1, 2016

Enrollment Period

2.6 years

First QC Date

December 1, 2011

Last Update Submit

March 9, 2016

Conditions

Postpartum Haemorrhage

Keywords

postpartum haemorrhagemisoprostoltreatmentprophylaxishome births

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-5 days after delivery

Secondary Outcomes (4)

  • Number of participants who experience side effects

    immediately after delivery; 3-5 days post delivery

  • number of participants who received additional interventions

    immediately after delivery; 3-5 days post delivery

  • number of women who found misoprostol treatment to be acceptable

    immediately after delivery; 3-5 days post delivery

  • number of participants who experience severe adverse events

    immediately after delivery; 3-5 days post delivery

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

women who experience a PPH will be randomized to receive 800 misoprostol (four tablets of 200 mcg administered sublingually)

Drug: Misoprostol

placebo

PLACEBO COMPARATOR

women who experience a PPH will be randomized to receive 4 placebo tablets administered sublingually

Other: placebo

Interventions

MisoprostolDRUG

4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth

Also known as: Gymiso
Misoprostol
placeboOTHER

4 tablets, administered sublingually if the woman experiences a PPH

Also known as: Gymiso
placebo

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Home Births

Chitral, Khyber Pakhtunkhwa, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 33232518DERIVED

  • Abbas 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.

    PMID: 30582753DERIVED

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPuerperal DisordersUterine HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Zafar Khan

    Aga Khan Health Services

    PRINCIPAL INVESTIGATOR

  • Nadeem Zuberi

    Aga Khan University

    STUDY DIRECTOR

  • Gijs Walraven

    Secretariat of His Highness the Aga Khan, Aiglemont

    STUDY DIRECTOR

  • Ayisha Diop

    Gynuity Health Projects

    STUDY DIRECTOR

  • Dina Abbas

    Gynuity Health Projects

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2011

First Posted

December 5, 2011

Study Start

May 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

March 10, 2016

Record last verified: 2016-03

Locations

PA(1)