Pregnancy Outcomes After Uterine Cavity Expansion

NCT03218878 — Completed, 9 participants, Reproductive Medicine Associates of New Jersey

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Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes

Registry	NCT03218878
Status	Completed
Study type	Observational
Enrollment	9 (Actual)
Sponsor	Reproductive Medicine Associates of New Jersey (Other)
Conditions	Miscarriage, Uterus Abnormal, Infertility
Dates	start 2017-07-21, primary completion 2018-09-01, completion 2018-09-10, first posted 2017-07-17, last updated 2018-10-15
Locations	1 site in United States

-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.

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+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.

+Outcome measures

Primary outcomes

Ongoing pregnancy [2 years]: presence of a fetal heartbeat at 8 weeks gestation

Secondary outcomes

Change in endometrial volume [1 month]: Increase or decrease in endometrial volume post-operatively as assessed by saline sonography
Time to conceive [2 years]: Time from post-operative visit to conception
Chemical pregnancy [2 years]: Positive pregnancy test
Clinical pregnancy [2 years]: Presence of a gestational sac on ultrasound
Pregnancy loss [2 years]: Miscarriage; either biochemical or clinical pregnancy loss
Ectopic pregnancy [2 years]: Pregnancy outside the uterus
Live birth [2 years]: Delivery of a liveborn infant
Obstetrical complications [2 years]: Any complications including hypertensive diseases, hemorrhage, etc.
Gestational age at delivery [2 years]: in weeks and days
Birthweight [2 years]: in grams

+Eligibility

Sex: Female, ages: 18 Years to any

Inclusion Criteria:

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

Exclusion Criteria:

* None

+Locations (1)

Facility	City	Country	Status
Reproductive Medicine Associates of New Jersey	Basking Ridge, New Jersey	United States

+Investigators

Linnea Goodman, MD, Principal investigator, Reproductive Medicine Associates of New Jersey

My Notes

Public

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