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Completed

NCT Number: NCT01570413

Pelvic Examination in Pregnancy

This study is designed to determine whether the pelvic examination (including bimanual and speculum examination) is necessary in patients with first trimester vaginal bleeding/ lower abdominal pain when an intra-uterine pregnancy (IUP) is seen on ultrasound. Patients with the chief complaint of vaginal bleeding or lower abdominal pain less than 16 weeks and positive HCG will be considered for this non-inferiority-designed clinical trial. All patients who present to the BMC Emergency Department (ED) Mon - Fri from 8am to 11pm and have had serum or urine HCG testing and a formal ultrasound by a credentialed emergency physician or radiology technician as part of standard of care will be screened for further eligibility. Those patients with intra-uterine pregnancies < 16 weeks gestation seen on ultrasound and meet inclusion criteria will then be asked to provide informed consent to participate in the study. Randomization will occur after consent has been obtained. Half of the patients will be randomized to receive pelvic examinations and the other half will not. Further care will be determined by the treating attending physician. The primary outcome will be a composite morbidity endpoint at 30 days, including return visits to the ED, emergency surgery, need for transfusion, infection, or other missed source of bleeding/ pain. Secondary outcomes of interest include ED throughput time, and patient satisfaction.

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Key information

Conditions

Early Pregnancy Bleeding Abdominal Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Boston Medical Center

Boston, Massachusetts, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chief complaint of vaginal bleeding or lower abdominal pain
  • Intra-uterine pregnancy seen on ultrasound
  • Date < 16 weeks by estimated LMP or ultrasound
  • Age >21
  • Ability to provide written informed consent
  • English speaking

Exclusion criteria

  • Already enrolled in study
  • Morbid Obesity (BMI > 40)
  • Pelvic exam performed prior to ultrasound results
  • Prisoner
  • Follow up cannot be assured
  • Admitted to hospital
  • Large amount of vaginal bleeding (>10 pads in 24 hours or equivalent)
  • Unstable vital signs (SBP<90 or HR>110)
  • Known cervical carcinoma in the past 1 year
  • Clinical suspicion for alternative syndrome that requires pelvic exam (such as severe pain consistent with ovarian torsion)
  • Report or suspicion of penetrating vaginal trauma
  • Suspicion of Active Labor
  • Reported Sexual Assault
  • Current pregnancy by IVF
  • IUD in place
  • Suspicion of heterotopic pregnancy on ultrasound

Treatment and study plan

No Pelvic Exam

Procedure

Will not receive pelvic examination.

Pelvic Examination

Procedure

Pelvic examination will be performed.

Primary outcomes

  1. Composite Morbidity Endpoint

    Time frame: 30 Days

    Adverse events include, but are not limited to, return visits to the Emergency Department, need for hospital admission, emergency procedure, transfusion, infection, or identification of other source of symptoms.

Secondary outcomes

  1. Patient Satisfaction

    Time frame: 24 Hours

  2. Throughput Time

    Time frame: 24 Hours

Sponsors and collaborators

Lead sponsor

Boston Medical Center

Other

Registry information

Official study title

Utility of Pelvic Examination in the Evaluation of Threatened Abortion

Acronym: PEP

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2012
Registry last updated
May 4, 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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