NCT03974841

Brief Summary

Cornual pregnancy is a rare form of ectopic pregnancy that accounts for 2% to 4% of ectopic pregnancies, with a mortality rate between 2.0% and 2.5%. Traditionally, interstitial pregnancies were treated by laparotomy with cornial resection or hysterectomy. However, nowadays, increasingly interstitial pregnancies are treated by laparoscopic cranial resection. Although this technique can potentially protect the fertility of the patient, it carries a serious risk of bleeding and requires a surgical experience.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 5, 2019

Completed
Last Updated

June 5, 2019

Status Verified

June 1, 2019

Enrollment Period

3 years

First QC Date

June 3, 2019

Last Update Submit

June 3, 2019

Conditions

Ectopic PregnancyLaparoscopicCornual Pregnancy

Outcome Measures

Primary Outcomes (2)

  • Operation time

    The duration of surgery of patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy

    surgery from start to end

  • amount of bleeding

    The amount of hemorrhage in patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy

    48 hours

Interventions

laparoscopic cornual resectionPROCEDURE

patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

postoperative results of patients who underwent laparoscopic cornual resection for cornual ectopic pregnancy, Patients forming the study group will be operated in the center for the last 3 years.

You may qualify if:

  • cornual ectopic pregnancy
  • Patients undergoing laparoscopic cornual wedge resection

You may not qualify if:

  • medical treatment area due to cornual pregnancy
  • laparotomy
  • conservatively managed patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Training and Research Hospital

Istanbul, 33404, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pregnancy, EctopicPregnancy, Cornual

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator, M.D, Department of Obstetrics and Gynecology

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 5, 2019

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

June 5, 2019

Record last verified: 2019-06

Locations

TU(1)