Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 8 for:    severe preeclampsia AND eclampsia | Panama
Previous Study | Return to List | Next Study

Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01988298
Recruitment Status : Completed
First Posted : November 20, 2013
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Tracking Information
First Submitted Date  ICMJE October 31, 2013
First Posted Date  ICMJE November 20, 2013
Last Update Posted Date July 28, 2015
Study Start Date  ICMJE October 2013
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
level of postpartum hypertension [ Time Frame: levels of hypertension up to 4 days post paertum ]
hypertension during the postpartum using acetaminophen or nonsteroidal antiinflammatory
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01988298 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2013)
complications [ Time Frame: complications during the postpartum period (4 days) ]
Renal failure, symptoms, bleeding
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 19, 2013)
convulsions [ Time Frame: maternal complicactions for 4 days postpartum ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Nonsteroidal Antiinflammatory Drugs in Women With Postpartum Pre-eclampsia
Official Title  ICMJE Ibuprofen Versus Acetaminophen in Women With Severe Pre-eclampsia After Vaginal Delivery.
Brief Summary

Hypertensive disorders of pregnancy are a major cause of maternal mortality and morbidity, especially in developing countries. Postpartum hypertension can be related to persistence of gestational hypertension, preeclampsia, or preexisting chronic hypertension, or it could develop de novo secondary to other causes. The available data in the medical literature have primarily focused on antenatal and peripartum management. There are few data regarding the evaluation in women who are diagnosis with postpartum hypertension. Some medications that cause vasoconstriction are often used for pain relief, in women having perineal lacerations, episiotomy, or cesarean delivery. Such women usually require large doses of nonsteroidal antiinflammatory drugs that are associated with vasoconstriction and sodium and water retention, this drugs can result in severe hypertension.

The purpose of this study is to evaluate maternal postpartum hypertension in women with severe preeclampsia treated with nonsteroidal antiinflammatory drugs or acetaminophen.

Detailed Description Our objective is evaluate Ibuprofen or acetaminophen used for pain during the postpartum period in women with severe pre-eclampsia. We include only women with vaginal delivery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Hypertension
Intervention  ICMJE
  • Drug: Ibuprofen
    Ibuprofen 400 mg each 8 hours
    Other Name: Ibuprofen in pre-eclampsia
  • Drug: Acetaminophen
    Control group
    Other Name: Acetaminophen in pre-eclampsia
Study Arms  ICMJE
  • Experimental: Ibuprofen
    Experimental: Ibuprofen 400 mg each 8 hours for 2-3 days.
    Intervention: Drug: Ibuprofen
  • Active Comparator: Acetaminophen
    Acetaminophen 1 g oral each 6 hours, 2-3 days.
    Intervention: Drug: Acetaminophen
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 27, 2015)
114
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2013)
124
Actual Study Completion Date  ICMJE February 2015
Actual Primary Completion Date February 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Vaginal delivery severe pre-eclampsia severe gestational hypertension aggregate pre-eclampsia

Exclusion Criteria:

sensitivities to ibuprofen cesarean delivery

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 44 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01988298
Other Study ID Numbers  ICMJE Complejoh 02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
Study Sponsor  ICMJE Complejo Hospitalario Dr. Arnulfo Arias Madrid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Paulino Vigil-De Gracia, MD Complejo Hospitalario Caja de Seguro social
PRS Account Complejo Hospitalario Dr. Arnulfo Arias Madrid
Verification Date July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP