Randomised double blind controlled trial of single dose methotrexate versus expectant management in women with tubal ectopic pregnancy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN95698259

Enrollment

Registered

2005-11-21

Start date

2005-08-15

Completion date

Unknown

Last updated

2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tubal ectopic pregnancy Pregnancy and Childbirth Ectopic pregnancy

Interventions

Women who fulfill the inclusion criteria and have normal blood results will be randomised to methotrexate treatment or placebo. Those having methotrexate will be given a single dose 50 mg/m^2. Women r

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Certain ultrasound diagnosis of tubal ectopic pregnancy 2. Clinically stable patient with no evidence of haematoperitoneum on ultrasound scan 3. Non-viable pregnancy 4. No history of liver or renal disease 5. Normal red and white cell count, renal and liver function tests 6. Inital serum human Chorionic Gonadotropin (hCG) less than 1500 IU/l 7. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Haemodynamic instability 2. Severe pain 3. History renal/liver/pulmonary disease 4. Blood dyscrasia 5. Haematoperitoneum 6. Foetal heart present 7. Written informed consent declined

Design outcomes

Primary

Measure	Time frame
The percentage of women successfully treated.	—

Secondary

Measure	Time frame
1. Complications such as tubal rupture, pain and the need for emergency surgery 2. Length of time followed up (i.e. time for beta-hCG to fall to below 20 IU/l)	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026