Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

NCT00719537 | Terminated Results DMC

• 1 other identifier: 2008-054
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.

Conditions

Preeclampsia

Keywords

preeclampsia; progesterone; aspirin; prevent; soluble fms-like tyrosine kinase (sFlt-1); Placental Growth Factor (PlGF); risk

Outcome Measures

Primary Outcomes (1)

• Incidence of Preeclampsia

  Number of Participants with preeclampsia in second and third trimester of pregnancy.

  second and third trimester of pregnancy

Study Arms (2)

Aspirin plus Placebo Oral Tablet

PLACEBO COMPARATOR

Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day

Drug: Aspirin; Drug: Placebo Oral Tablet

Aspirin plus Progesterone

ACTIVE COMPARATOR

Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day

Drug: Aspirin; Drug: Progesterone

Interventions

Aspirin DRUG

Aspirin 81 mg once a day

Aspirin plus Placebo Oral Tablet; Aspirin plus Progesterone

Placebo Oral Tablet DRUG

Placebo 1 tab Daily

Aspirin plus Placebo Oral Tablet

Progesterone DRUG

Oral Progesterone 200 mg Twice Daily

Aspirin plus Progesterone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy.
• to 45 years of age will be included.

You may not qualify if:

• Patients with chronic hypertension
• children (age \< 17 years)
• Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors
• patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.

Sponsors & Collaborators

• John Uckele: lead

Study Sites (1)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin; Progesterone

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Results Point of Contact

• Title: John Uckele
• Organization: William Beaumont Hospital

john.uckele@beaumont.edu

2485510610

Study Officials

• John E Uckele, MD

  Corewell Health East

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: July 17, 2008
• First Posted: July 21, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: April 17, 2017
• Results First Posted: April 17, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)