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Completed

NCT Number: NCT03028194

Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia

Use of Postpartum uterine curettage in reducing hospitalization time or in improving the clinical evolution of the patient with preeclampsia/eclampsia.

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Key information

Conditions

Pre-eclampsia Eclampsia Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Pregnancy Complications Urogenital Diseases

Age range

15 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Saint Thomas H, Panama City, Provincia de Panamá, Panama

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About this study

To evaluate if postpartum uterine curettage improved the clinical and laboratory parameters in patients with preeclampsia or eclampsia.

A total of 442 patients with preeclampsia/eclampsia were randomized to postpartum curettage (223) or no procedure (219). Systolic and diastolic blood pressure were recorded and analyzed at hours 6, 12, 24 and 48. Also, several laboratory values and diuresis were evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Gestational age 24 weeks or more.
  • Preeclampsia/eclampsia

Exclusion criteria

  • Epilepsy or seizures previous to pregnancy.
  • Renal disease
  • Heart disease
  • Liver disease

Treatment and study plan

Curettage

Procedure

Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.

Placebo

Procedure

No procedure after delivery of the placenta

Primary outcomes

  1. Systolic and diastolic blood pressure

    Time frame: 6 hours

    Arterial blood pressure

  2. Systolic and diastolic blood pressure

    Time frame: 12 hours

    Arterial blood pressure

  3. Systolic and diastolic blood pressure

    Time frame: 24 hours

    Arterial blood pressure

  4. Systolic and diastolic blood pressure

    Time frame: 48 hours

    Arterial Blood pressure

Secondary outcomes

  1. Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    Time frame: 6 hours

    Number of patients with an abnormal laboratory value

  2. Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    Time frame: 12 hours

    Number of patients with an abnormal laboratory value

  3. Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    Time frame: 24 hours

    Number of patients with an abnormal laboratory value

  4. Laboratory results (hypertensive disorder profile: hemoglobin, hematocrit, platelets, renal or liver function tests).

    Time frame: 48 hours

    Number of patients with an abnormal laboratory value

  5. Seizures

    Time frame: 48 hours

    Number of participants with the development of seizures after birth.

Sponsors and collaborators

Lead sponsor

Saint Thomas Hospital, Panama

Other

Registry information

Official study title

Effects of Postpartum Uterine Curettage in the Recovery From Preeclampsia/Eclampsia: A Randomized, Controlled Trial

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 23, 2017
Registry last updated
Jan 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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