MiscarriageNCT03218878
Pregnancy Outcomes After Uterine Cavity Expansion
An observational study of Miscarriage and Uterus Abnormal, run by Reproductive Medicine Associates of New Jersey at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Miscarriage, Uterus Abnormal, Infertility
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2017to 10 Sep 2018
- Phase
- Observational
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients at an infertility clinic who are scheduled to undergo hysteroscopic expansion of the uterine cavity
Who may be able to join
- Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United States1 site
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, 07920
About this study
Official title: Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes
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.
Read the 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.
- Conditions
- Miscarriage, Uterus Abnormal, Infertility
- Medical subject headings
- Abortion, Spontaneous, Uterine Anomalies, Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy
presence of a fetal heartbeat at 8 weeks gestation
Measured: 2 years
Secondary outcomes (10)
Change in endometrial volume
Increase or decrease in endometrial volume post-operatively as assessed by saline sonography
Measured: 1 month
Time to conceive
Time from post-operative visit to conception
Measured: 2 years
Chemical pregnancy
Positive pregnancy test
Measured: 2 years
Clinical pregnancy
Presence of a gestational sac on ultrasound
Measured: 2 years
Pregnancy loss
Miscarriage; either biochemical or clinical pregnancy loss
Measured: 2 years
Ectopic pregnancy
Pregnancy outside the uterus
Measured: 2 years
Live birth
Delivery of a liveborn infant
Measured: 2 years
Obstetrical complications
Any complications including hypertensive diseases, hemorrhage, etc.
Measured: 2 years
Gestational age at delivery
in weeks and days
Measured: 2 years
Birthweight
in grams
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2017
- Study start21 Jul 2017
- Primary completion1 Sep 2018
- Study completion10 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MiscarriageStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Medicine Associates of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linnea Goodman, MD, Principal investigator, Reproductive Medicine Associates of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218878
- Sponsor's protocol ID
- RMA-2017-04
- Status last verified
- Oct 2018
- First submitted
- 13 Jul 2017
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pregnancy Outcomes Following Hysteroscopic Expansion of the Uterine Cavity for Patients With Small Cavities and Poor Reproductive Outcomes
- ClinicalTrials.gov ID
- NCT03218878
- Acronym / sponsor ID
- RMA-2017-04
- Conditions
- Miscarriage, Uterus Abnormal, Infertility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Reproductive Medicine Associates of New JerseyUniversity, hospital or other
- Study start
- 21 Jul 2017 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 10 Sep 2018 (actual)
- First posted
- 17 Jul 2017 (actual)
- 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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at an infertility clinic who are scheduled to undergo hysteroscopic expansion of the uterine cavity
Key inclusion criteria (1 listed)
- Any patient scheduled to undergo hysteroscopic expansion of the uterine cavity
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Ongoing pregnancy
Time frame: 2 years
presence of a fetal heartbeat at 8 weeks gestation
10 secondary outcomes
Change in endometrial volume
Time frame: 1 month
Time to conceive
Time frame: 2 years
Chemical pregnancy
Time frame: 2 years
Clinical pregnancy
Time frame: 2 years
Pregnancy loss
Time frame: 2 years
Ectopic pregnancy
Time frame: 2 years
Live birth
Time frame: 2 years
Obstetrical complications
Time frame: 2 years
Gestational age at delivery
Time frame: 2 years
Birthweight
Time frame: 2 years
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 15 Oct 2018.
- Individual participant dataSharing planned: Undecided
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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.
Linnea Goodman, MD principal investigator
Reproductive Medicine Associates of New Jersey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Miscarriage and Uterus Abnormal, run by Reproductive Medicine Associates of New Jersey 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 1 inclusion and 1 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 15 Oct 2018. 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?
Ongoing pregnancy (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Oct 2018.