Early Pregnancy BleedingPEPNCT01570413
Pelvic Examination in Pregnancy
A study testing No Pelvic Exam and Pelvic Examination in people with Early Pregnancy Bleeding and Abdominal Pain, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Early Pregnancy Bleeding, Abdominal Pain
- What is being tested?
- No Pelvic Exam and Pelvic Examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Jan 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Already enrolled in study
- Morbid Obesity (BMI > 40)
- Pelvic exam performed prior to ultrasound results
- Prisoner
- Follow up cannot be assured
- Admitted to hospital
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Utility of Pelvic Examination in the Evaluation of Threatened Abortion
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
- Being tested
- No Pelvic Exam, Pelvic Examination
- Medical subject headings
- Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Pelvic ExamProcedure or surgery
Will not receive pelvic examination.
Pelvic ExaminationProcedure or surgery
Pelvic examination will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Pelvic Exam | Active comparator | Subjects receive pelvic exam Receives: Procedure: Pelvic Examination |
| No Pelvic Exam | Experimental | Subjects do not receive pelvic exam Receives: Procedure: No Pelvic Exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Morbidity Endpoint
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.
Measured: 30 Days
Secondary outcomes (2)
Patient Satisfaction
Measured: 24 Hours
Throughput Time
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Early Pregnancy BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Judith Linden, Boston Medical Center
- Investigators
- Judith Linden, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01570413
- Sponsor's protocol ID
- H-31421
- Acronym
- PEP
- Status last verified
- May 2017
- First submitted
- 27 Feb 2012
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21691528Brown 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.
PubMed 17475104Hoey 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.
PubMed 15208231Isoardi 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.
PubMed 20002713Seymour 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.
PubMed 20159393
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Pelvic Examination in the Evaluation of Threatened Abortion
- ClinicalTrials.gov ID
- NCT01570413
- Acronym / sponsor ID
- PEP / H-31421
- Conditions
- Early Pregnancy Bleeding, Abdominal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 4 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pelvic Exam | Active comparator | Procedure: Pelvic ExaminationSubjects receive pelvic exam |
| No Pelvic Exam | Experimental | Procedure: No Pelvic ExamSubjects do not receive pelvic exam |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- Already enrolled in study
- Morbid Obesity (BMI > 40)
- Pelvic exam performed prior to ultrasound results
- Prisoner
- Follow up cannot be assured
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No Pelvic ExamWill not receive pelvic examination. | Procedure or surgery | No Pelvic Exam |
| Pelvic ExaminationPelvic examination will be performed. | Procedure or surgery | Pelvic Exam |
Primary outcome
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.
2 secondary outcomes
Patient Satisfaction
Time frame: 24 Hours
Throughput Time
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Background: PubMed 21691528Brown 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.
- Background: PubMed 17475104Brown 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.
- Background: PubMed 15208231Hoey 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.
- Background: PubMed 20002713Isoardi 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.
- Background: PubMed 20159393Seymour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Judith Linden, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Pelvic Exam and Pelvic Examination in people with Early Pregnancy Bleeding and Abdominal Pain, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Morbidity Endpoint (time frame: 30 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01570413, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2017.