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Pregnancy Outcomes After Uterine Cavity Expansion

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218878
Recruitment Status : Completed
First Posted : July 17, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
Reproductive Medicine Associates of New Jersey

Study Description
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Brief Summary:
This study seeks to evaluate pregnancy outcomes following hysteroscopic uterine cavity expansion surgery for patients with dysmorphic uterine cavities and poor reproductive histories. Patients already planning to undergo surgery at the recommendation of their physicians will be recruited for participation.

Condition or disease
Miscarriage Uterus Abnormal Infertility

Detailed Description:
Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity at RMANJ is eligible to participate in the study. Patients will be approached for consent to participate in the study prior to undergoing surgery. If enrolled, outcomes following surgery will be followed and recorded.
Study Design
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Study Type : Observational
Actual Enrollment : 9 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes
Actual Study Start Date : July 21, 2017
Actual Primary Completion Date : September 1, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy [ Time Frame: 2 years ]
    presence of a fetal heartbeat at 8 weeks gestation


Secondary Outcome Measures :
  1. Change in endometrial volume [ Time Frame: 1 month ]
    Increase or decrease in endometrial volume post-operatively as assessed by saline sonography

  2. Time to conceive [ Time Frame: 2 years ]
    Time from post-operative visit to conception

  3. Chemical pregnancy [ Time Frame: 2 years ]
    Positive pregnancy test

  4. Clinical pregnancy [ Time Frame: 2 years ]
    Presence of a gestational sac on ultrasound

  5. Pregnancy loss [ Time Frame: 2 years ]
    Miscarriage; either biochemical or clinical pregnancy loss

  6. Ectopic pregnancy [ Time Frame: 2 years ]
    Pregnancy outside the uterus

  7. Live birth [ Time Frame: 2 years ]
    Delivery of a liveborn infant

  8. Obstetrical complications [ Time Frame: 2 years ]
    Any complications including hypertensive diseases, hemorrhage, etc.

  9. Gestational age at delivery [ Time Frame: 2 years ]
    in weeks and days

  10. Birthweight [ Time Frame: 2 years ]
    in grams


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients at an infertility clinic who are scheduled to undergo hysteroscopic expansion of the uterine cavity
Criteria

Inclusion Criteria:

  • Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218878


Locations
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United States, New Jersey
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Sponsors and Collaborators
Reproductive Medicine Associates of New Jersey
Investigators
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Principal Investigator: Linnea Goodman, MD Reproductive Medicine Associates of New Jersey
More Information
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Responsible Party: Reproductive Medicine Associates of New Jersey
ClinicalTrials.gov Identifier: NCT03218878    
Other Study ID Numbers: RMA-2017-04
First Posted: July 17, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Abortion, Spontaneous
Pregnancy Complications