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OpenTrials
Completed

NCT Number: NCT01606774

A Modernized Approach to Prenatal Care in Low Risk Women

The investigators plan to identify 80 pregnant women at low risk for obstetrical complications and replace 4-5 routine third trimester visits with a structured program of home weight, blood pressure and urine protein monitoring along with regular structured phone interviews and a 28 week ultrasound. The investigators hypothesis is that this protocol is both safe and acceptable.

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Key information

Conditions

Pre-eclampsia Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Fetal Growth Retardation Growth Disorders Hypertension, Pregnancy-Induced Intrauterine Growth Retardation Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Urogenital Diseases

Age range

Up to 35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age < 35
  • Doesn't live alone
  • Current phone number
  • Previous pregnancy
  • No prior second trimester miscarriage/fetal loss after 13 weeks
  • Previous delivery
  • If yes, all had uncomplicated antepartum course
  • All Deliveries > 37 weeks
  • All birth weight > 2700 grams
  • Maternal BMI between 18.5 and 30
  • No chronic medical problems
  • No current substance abuse
  • Spontaneous conception
  • No family history of pre-eclampsia
  • Agrees to first trimester aneuploidy screening

Exclusion criteria

  • Clinically significant abnormalities on routine physical exam or routine laboratory results
  • Multiple pregnancy
  • Fetal abnormalities detected on either the 11-14 week or the 18 week ultrasound including a nuchal translucency > 3 mm but not including second trimester markers for aneuploidy or a low lying placenta
  • A risk of fetal aneuploidy on first trimester screening > 1:300 PAPP-A < 5 %ile or HCG < 1 %ile (abnormalities of these serum analytes routinely obtained as part of aneuploidy screening are associated with an increased risk of adverse outcome)
  • Elevated blood pressure (> 140/90),
  • Cervical length < 3 cm at the 18 week ultrasound (which is associated with an increased risk for preterm delivery).

Treatment and study plan

Modernized prenatal care

Other

Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks

Primary outcomes

  1. Unanticipated pregnancy complications

    Time frame: Gestational age 18-36 weeks

    Any maternal and/or fetal adverse outcome that was not detected, but could have been detected by routine antepartum visits between 18 and 36 weeks

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
May 28, 2012
Registry last updated
Feb 6, 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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