Pelvic Examination in Pregnancy

NCT ID: NCT01570413

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 220 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-01-31

Brief Summary

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.

Conditions

Early Pregnancy Bleeding; Abdominal Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Pelvic Exam

Subjects receive pelvic exam

Group Type: ACTIVE_COMPARATOR

Pelvic Examination

Intervention Type: PROCEDURE

Pelvic examination will be performed.

No Pelvic Exam

Subjects do not receive pelvic exam

Group Type: EXPERIMENTAL

No Pelvic Exam

Intervention Type: PROCEDURE

Will not receive pelvic examination.

Interventions

No Pelvic Exam

Will not receive pelvic examination.

Intervention Type: PROCEDURE

Pelvic Examination

Pelvic examination will be performed.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Chief complaint of vaginal bleeding or lower abdominal pain

2. Intra-uterine pregnancy seen on ultrasound

3. Date < 16 weeks by estimated LMP or ultrasound

4. Age >21

5. Ability to provide written informed consent

6. English speaking

Exclusion Criteria

1. Already enrolled in study

2. Morbid Obesity (BMI > 40)

3. Pelvic exam performed prior to ultrasound results

4. Prisoner

5. Follow up cannot be assured

6. Admitted to hospital

7. Large amount of vaginal bleeding (>10 pads in 24 hours or equivalent)

8. Unstable vital signs (SBP<90 or HR>110)

9. Known cervical carcinoma in the past 1 year

10. Clinical suspicion for alternative syndrome that requires pelvic exam (such as severe pain consistent with ovarian torsion)

11. Report or suspicion of penetrating vaginal trauma

12. Suspicion of Active Labor

13. Reported Sexual Assault

14. Current pregnancy by IVF

15. IUD in place

16. Suspicion of heterotopic pregnancy on ultrasound

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Judith Linden

BMC Faculty

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Judith Linden, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

References

Brown J, Fleming R, Aristzabel J, Gishta R. Does pelvic exam in the emergency department add useful information? West J Emerg Med. 2011 May;12(2):208-12.

Reference Type: BACKGROUND

PMID: 21691528 (View on PubMed)

Brown T, Herbert ME. Medical myth: Bimanual pelvic examination is a reliable decision aid in the investigation of acute abdominal pain or vaginal bleeding. CJEM. 2003 Mar;5(2):120-2. doi: 10.1017/s1481803500008289.

Reference Type: BACKGROUND

PMID: 17475104 (View on PubMed)

Hoey R, Allan K. Does speculum examination have a role in assessing bleeding in early pregnancy? Emerg Med J. 2004 Jul;21(4):461-3. doi: 10.1136/emj.2003.012443.

Reference Type: BACKGROUND

PMID: 15208231 (View on PubMed)

Isoardi K. Review article: the use of pelvic examination within the emergency department in the assessment of early pregnancy bleeding. Emerg Med Australas. 2009 Dec;21(6):440-8. doi: 10.1111/j.1742-6723.2009.01227.x.

Reference Type: BACKGROUND

PMID: 20002713 (View on PubMed)

Seymour A, Abebe H, Pavlik D, Sacchetti A. Pelvic examination is unnecessary in pregnant patients with a normal bedside ultrasound. Am J Emerg Med. 2010 Feb;28(2):213-6. doi: 10.1016/j.ajem.2008.10.018.

Reference Type: BACKGROUND

PMID: 20159393 (View on PubMed)

Other Identifiers

H-31421

Identifier Type: -

Identifier Source: org_study_id