Dataset Information

Treatment success with two doses of methotrexate vs single dose of methotrexate in Ectopic Tubal Pregnancy.

ABSTRACT:

Objectives

To compare the success rates and safety of two-doses of methotrexate versus single dose of methotrexate in ectopic tubal pregnancy.

Methods

This was an open-label, randomized controlled trial done at "The Department of Obstetrics & Gynecology, Nishtar University Hospital, Multan" from January 2020 to July 2021. A total of 100 women (50 in each group), aged 20 to 35 years with a tubal ectopic pregnancy were enrolled. All patients were randomly allocated to either single-dose or two-dose methotrexate protocol. Cases were evaluated for treatment success, side effects, beta-human chorionic gonadotrophin (β-hCG) resolution time and treatment satisfaction.

Results

In a total of 100 cases, mean age was 29.6±4.5 years. Mean serum β -hCG levels at baseline was 1212±78 mIU/ml. Treatment success was noted among 43 (86.0%) cases of single-dose group versus 45 (90.0%) cases (p=0.5382). Duration of β -hCG resolution time was significantly shorter in two-dose group (23.0±12.1 days versus 28.2±12.8 days, p=0.0394). No significant difference was noted in methotrexate associated side effects in both study groups (p=0.9996). Overall, mean satisfaction score was 4.0±1.3 (out of 5).

Conclusion

Although, β -hCG resolution time was significantly low in two-dose protocol but single-dose methotrexate offered comparable success rates versus two-dose protocol. Side effects were mild and comparable in both methotrexate treatment protocols. Methotrexate was found to be effective in the medical management of ectopic pregnancy.

SUBMITTER: Khakwani M

PROVIDER: S-EPMC9378401 | biostudies-literature | 2022 Jul-Aug

REPOSITORIES: biostudies-literature

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Publications

Treatment success with two doses of methotrexate vs single dose of methotrexate in Ectopic Tubal Pregnancy.

Khakwani Mehnaz M Parveen Rashida R Ali Syeda S

Pakistan journal of medical sciences 20220701 6

<h4>Objectives</h4>To compare the success rates and safety of two-doses of methotrexate versus single dose of methotrexate in ectopic tubal pregnancy.<h4>Methods</h4>This was an open-label, randomized controlled trial done at "The Department of Obstetrics & Gynecology, Nishtar University Hospital, Multan" from January 2020 to July 2021. A total of 100 women (50 in each group), aged 20 to 35 years with a tubal ectopic pregnancy were enrolled. All patients were randomly allocated to either single- ...[more]

PMID: 35991243

Similar Datasets

Project description:ObjectiveTo compare the treatment success and failure rates, as well as side effects and surgery rates, between methotrexate protocols.Data sourcesPubMed, Embase, and the Cochrane library searched up to July 2018.Study eligibility criteriaRandomized controlled trials that compared women with ectopic pregnancies receiving the single-dose, two-dose, or multi-dose methotrexate protocols.Study appraisal and synthesis methodsOdds of treatment success, treatment failure, side effects, and surgery for tubal rupture, as well as length of follow-up until treatment success, were compared using random and fixed effects meta-analysis. Sensitivity analyses compared treatment success in the groups with high human chorionic gonadatropin (hCG) values and a large adnexal mass, as defined by individual studies. The Cochrane Collaboration tool was used to assess risk of bias.ResultsThe 2-dose protocol was associated with higher treatment success compared to the single-dose protocol (odds ratio [OR], 1.84; 95% CI, 1.13, 3.00). The 2-dose protocol was more successful in women with high hCG (OR, 3.23; 95% CI, 1.53, 6.84) and in women with a large adnexal mass (OR, 2.93; 95% CI, 1.23, 6.9). The odds of surgery for tubal rupture were lower in the 2-dose protocol (OR, 0.65; 95% CI, 0.26, 1.63), but this was not statistically significant. The length of follow-up was 7.9 days shorter for the 2-dose protocol (95% CI, -12.2, -3.5). The odds of side effects were higher in the 2-dose protocol (OR, 1.53; 95% CI, 1.01, 2.30). Compared to the single-dose protocol, the multi-dose protocol was associated with a nonsignificant reduction in treatment failure (OR, 0.56; 95% CI, 0.28, 1.13) and a higher chance of side effects (OR, 2.10; 95% CI, 1.24, 3.54). The odds of surgery for tubal rupture (OR, 1.62; 95% CI, 0.41, 6.49) and time to follow-up (OR, -1.3; 95% CI, -5.4, 2.7) were similar.ConclusionThe 2-dose methotrexate protocol is superior to the single-dose protocol for the treatment of ectopic pregnancy in terms of treatment success and time to success. Importantly, these findings hold true in patients thought to be at a lower likelihood of responding to medical management, such as those with higher hCGs and a large adnexal mass.

Project description:Non-tubal ectopic pregnancies are a rare subgroup of ectopic pregnancies implanted at sites other than the Fallopian tube. Mortality from non-tubal ectopic pregnancies is higher compared with that for tubal ectopic pregnancies, and they are becoming more common, partly due to the rising incidence of Caesarean sections and use of assisted reproductive technologies. Non-tubal ectopic pregnancies can be especially difficult to treat. Surgical treatment is complex, and follow-up after medical treatment is usually protracted. There is therefore a need for more effective medical therapies to resolve non-tubal ectopic pregnancies and reduce operative intervention. We have recently reported successful use of combination gefitinib (an orally available epidermal growth factor receptor inhibitor) and methotrexate for treatment of tubal pregnancies. To our knowledge, this combination has not been used to treat non-tubal pregnancies. Here we report the use of combination gefitinib and methotrexate to treat eight women with stable, non-tubal ectopic pregnancies at two tertiary academic teaching hospitals (Edinburgh, UK and Melbourne, Australia); five interstitial and three Caesarean section scar ectopic pregnancies. Pretreatment serum hCG levels ranged from 2458 to 48 550 IU/l, and six women had pretreatment hCG levels >5000 IU/l. The women were co-administered 1-2 doses of i.m. methotrexate (50 mg/m² on Day 1, ± Day 4 or Day 7) with seven once daily doses of oral gefitinib (250 mg). The women were monitored until complete resolution of the ectopic pregnancy, defined as a serum hCG <15 IU/l. Time to resolution (days from first methotrexate dose until serum hCG <15 IU/l), safety and tolerability, complication rates and subsequent fertility outcomes were also recorded. All eight women were successfully treated with combination gefitinib and methotrexate. The most common side effects were transient acne/rash and diarrhoea, known side effects of gefitinib. All women promptly resumed menstruation and importantly, three women subsequently conceived spontaneously. Two have delivered a healthy infant at term and the third is currently in her second trimester of pregnancy. Hence, our case series supports a future clinical trial to determine the efficacy of combination gefitinib and methotrexate to treat non-tubal ectopic pregnancies.

Dataset Information

Treatment success with two doses of methotrexate vs single dose of methotrexate in Ectopic Tubal Pregnancy.

Objectives

Methods

Results

Conclusion

Publications

Treatment success with two doses of methotrexate vs single dose of methotrexate in Ectopic Tubal Pregnancy.

Similar Datasets

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