Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03253588
Other study ID # 106002-E
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 21, 2017
Est. completion date October 15, 2017

Study information

Verified date July 2019
Source Far Eastern Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Traditionally, salpingectomy has been the standard procedure for managing ectopic pregnancy. We would like to evaluate the safety and efficacy of laparoscopic tubal preservation surgery in treating ectopic pregnancies (salpingostomy or salpingotomy) while preserving the fertility outcome of the patients, as well as to identify the factors predicting the presence of persistent ectopic pregnancy after the surgery.


Description:

All surgically-treated ectopic pregnancies in women aged 20 and above between 01 January 2009 and 31 December 2016 were identified. Cases receiving laparoscopic salpingostomy or laparoscopic salpingotomy were extracted from the database, patient characteristics and surgical outcomes (changes of serumĪ²-hcg, presence of persistent ectopic pregnancy and subsequent management, subsequent pregnancy) were reviewed from their medical records. Univariate and multivariate logistic regression analysis were employed to predict the presence of persistent ectopic pregnancy after laparoscopic tubal preservation surgery.


Recruitment information / eligibility

Status Completed
Enrollment 100
Est. completion date October 15, 2017
Est. primary completion date September 15, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 20 Years to 50 Years
Eligibility Inclusion Criteria:

- women who had laparoscopic tubal preservation surgery (including salpingostomy and salpingotomy) for ectopic pregnancy between January 2009 and November 2016

Exclusion Criteria:

- women with ectopic pregnancy at sites other than fallopian tube (i.e. interstitial, ovary, abdomen)

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
laparoscopic salpingotomy or salpingostomy
A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).

Locations

Country Name City State
Taiwan Far Eastern Memorial Hospital Taipei New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Far Eastern Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary peri- and post-operative parameters success rate of tubal preservation surgery (defined by postoperative serum bcg <5 IU/mL), postoperative complications (number of women who had adverse surgical outcome such as bladder injury, bowel injury, massive bleeding), pregnancy outcome (number of women who conceived successfully following the intervention) between January 2009 and November 2016
Secondary factors affecting the surgical success rate relationship between patient's baseline characteristics and rate of persistent ectopic pregnancy (unvariate and multivariate analysis) between January 2009 and November 2016
See also
  Status Clinical Trial Phase
Completed NCT02995356 - Evaluation of the Axonemal Dynein Heavy Chain 5 and Creatine Kinase Concentration in Cervical Fluid for Early Detection of the Ectopic Pregnancy
Completed NCT01876004 - Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy Phase 4
Not yet recruiting NCT05039853 - Improving Mental Health Following Early PREgnancy Loss Using a Brief Cognitive Task N/A
Completed NCT00194207 - Risk Factors of Ectopic Pregnancy N/A
Completed NCT00827970 - Randomized Population-Based Study on Chlamydia Trachomatis Screening N/A
Recruiting NCT05374720 - Analysis of the Molecular Composition of Tubal Cilia in Patients With or Without Ectopic Pregnancy N/A
Completed NCT03894735 - Vitamin D in Ectopic Pregnancies
Recruiting NCT01860690 - BHCG Level in Day 4,7, in Comparison to Day 10 as an Indicator for Treatment Success Phase 4
Recruiting NCT04176549 - Assessment of Biomarkers in Ectopic Pregnancy
Not yet recruiting NCT05890066 - Single-port Versus Multi-port Laparoscopic Surgery for Ectopic Pregnancy N/A
Completed NCT01855568 - Methotrexate Treatment for Ectopic Pregnancy Phase 3
Not yet recruiting NCT04308343 - The Aromatase Inhibitor and Gnrh Antagonist Versus Methotrexate for Management of Undisturbed Ectopic Pregnancy N/A
Recruiting NCT06354439 - Use of Letrozole for Ectopic Pregnancy Phase 4
Not yet recruiting NCT06300333 - Treatment of Ectopic Pregnancy by Low Dose of Methotrexate
Completed NCT00194272 - Two-Dose Methotrexate for Ectopic Pregnancy Phase 3
Enrolling by invitation NCT03579550 - Hysteroscopic Metroplasty in Unexplained Infertile Women With Dysmorphic Uterus N/A
Completed NCT05446012 - Relationship Between Ectopic Pregnancy and Thyroid Disorders
Completed NCT00194168 - Ectopic Pregnancy Biomarkers N/A
Completed NCT02152696 - Optimal Treatment for Women With a Persisting Pregnancy of Unknown Location Phase 3
Not yet recruiting NCT04975984 - Expectant Management of Ectopic Pregnancy