Pregnancy Outcomes After Uterine Cavity Expansion

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03218878

Enrollment

Registered

2017-07-17

Start date

2017-07-21

Completion date

2018-09-10

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility, Miscarriage, Uterus Abnormal

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
Ongoing pregnancy	2 years	presence of a fetal heartbeat at 8 weeks gestation

Secondary

Measure	Time frame	Description
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
Change in endometrial volume	1 month	Increase or decrease in endometrial volume post-operatively as assessed by saline sonography
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
Ectopic pregnancy	2 years	Pregnancy outside the uterus

Countries

United States

Outcome results