Clinical trial NCT01855568: Methotrexate Treatment for Ectopic Pregnancy
Official title: Comparison of Two-dose and Single-dose Methotrexate Protocol for Ectopic Pregnancy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ectopic Pregnancy
Lead sponsor: CHA University
Sponsor class: OTHER
First posted: 2013-05-16
Enrollment: 92
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Ectopic pregnancy is an important cause of maternal morbidity and occasionally mortality. Deaths associated with ectopic pregnancy have declined, though approximately 75% of deaths in the first trimester and 9-13% of all pregnancy-related deaths are associated ectopic pregnancy. The main stays of management for ectopic pregnancy were surgery and medical treatment. Medical management with systemic methotrexate administration avoids the inherent morbidity of anesthesia and surgery is cost-effective, and also offers success rates comparable to surgical management, with no loss in future potential fertility.

However, although medical management using methotrexate is used commonly, there is no solid consensus regarding dose protocol. Currently, there are three methotrexate protocols for the treatment of an ectopic pregnancy, "multi-dose", "single-dose", or "two-dose". Among them, the multi-dose protocol includes the administration of 4 methotrexate doses alternating with leucovorin (rescue regimen). As a result of the multiple dosing of methotrexate, side effects are more common. In contrast, the advantages of the single-dose protocol include elimination of a rescue regimen, lower incidence of adverse effects, and better compliance. However, the single-dose protocol was found to be associated with a considerably lower success rate as compared with the multi-dose protocol (88% versus 93%) in a recent meta-analysis. The two-dose protocol, which it balances efficacy and safety/convenience, was described as a cross between the multi-dose and single-dose protocols.

However, there were a few studies comparing between single-dose and two-dose protocol. The purpose of this prospective randomized trial was to compared the success rates of single-dose and two-dose methotrexate protocol for the treatment of tubal ectopic pregnancy.


Eligibility criteria: Inclusion Criteria:

* tubal pregnancy
* tubal pregnancy except interstitial pregnancy
* a pretreatment β-hCG level \<15000 mIU/mL
* a gestational sac with a largest diameter \<4 cm
* hemodynamically stable status
* agreement to methotrexate treatment and follow up

Exclusion Criteria:

* heterotrophic pregnancy
* a presence of embryonic cardiac motion
* clinically or sonographically suspected tubal rupture
* laboratory tests showing possible deleterious effects of methotrexate treatment on organ functions

Primary outcomes:
measure: treatment success
timeFrame: Up to 8 weeks (normal recovery time after treatment)
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: CHA Gangnam Medical Center
Study officials:
affiliation: CHA Gangnam Medical Center, Seoul, Republic of Korea
name: Taejong Song, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Song T, Kim MK, Kim ML, Jung YW, Yun BS, Seong SJ. Single-dose versus two-dose administration of methotrexate for the treatment of ectopic pregnancy: a randomized controlled trial. Hum Reprod. 2016 Feb;31(2):332-8. doi: 10.1093/humrep/dev312. Epub 2015 Dec 23.