NCT00070746

Brief Summary

There are large differences in health outcomes related to pregnancy and birth between developed and developing countries. This study will investigate how infections, medical history, health care behavior and psychosocial issues are associated with pregnancy outcomes in Pakistan.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2003

Typical duration for all trials

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

Study Start

First participant enrolled

June 1, 2003

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 7, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2003

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
Last Updated

July 31, 2014

Status Verified

July 1, 2014

First QC Date

October 7, 2003

Last Update Submit

July 29, 2014

Conditions

Bacterial VaginosisFetal Membranes, Premature RuptureChorioamnionitisPregnancy

Keywords

Perinatal mortality [PNM]Neonatal mortalityLow birth weight [LBW]Spontaneous preterm delivery [SPTD]Premature rupture of membranes [PROM]Histological chorioamnionitisGlobal NetworkPakistanMaternal and child healthInternationalWomen's health

Eligibility Criteria

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

You may qualify if:

  • Participants must
  • be in their 20th to 26th week of pregnancy (to be confirmed by an ultrasound)
  • be permanent residents (resident for the past months or intending to stay for next the 6 months) of the study site in Hyderabad, Pakistan; and,
  • give informed (written or verbal) consent.

You may not qualify if:

  • have clinical diagnoses of life-threatening conditions (requiring immediate treatment or hospitalization, as diagnosed by the attending physician).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health clinic

Hyderābād, Pakistan

Location

Related Links

MeSH Terms

Conditions

Vaginosis, BacterialFetal Membranes, Premature RuptureChorioamnionitis

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginitisVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObstetric Labor ComplicationsPregnancy ComplicationsFetal DiseasesPlacenta DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Robert Goldenberg, MD

    Drexel University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2003

First Posted

October 10, 2003

Study Start

June 1, 2003

Study Completion

July 1, 2005

Last Updated

July 31, 2014

Record last verified: 2014-07

Locations

PA(1)