Effectiveness Of Expectant Management In The Tubal Ectopic Pregnancy

Status Completed

Clinical Trial Summary

Objectives: To evaluate if, when considering expectant management in tubal ectopic pregnancy if the complementary use of Methotrexate could provide better results. We evaluate the success of treatment and the time required for titers of β-hCG to become negative. Methods: A double-blind randomized study, held at the Department of Obstetrics UNIFESP. The patients will be divided into two groups: in one patients will be administered a single intramuscular dose of 50 mg/m2 of Methotrexate and in the other patients will be prescribed Placebo intramuscularly. The monitoring will be done by measurement of β-hCG in the 4th and 7th day. When the decline of beta-hCG titers was > 15% in this interval, the patient was followed with weekly dosing of β-hCG until the titers become negative. The criterion of success is when the β-hCG was negative. The treatment failure occurs when surgery was necessary.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01876004
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	Phase 4
Start date	September 2011
Completion date	June 2013

View Details

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
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
Completed	`NCT04371991` - Kisspeptin Levels in Early Pregnancy