Pilot randomised controlled trial of hysteroscopic septal resection

Assessment of hysteroscopic metroplasty in women with a uterine septum and a history of miscarriage: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN28960271

Enrollment

Registered

2015-01-27

Start date

2015-12-09

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Women with septate uteri, a history of miscarriage or preterm birth, or infertility Pregnancy and Childbirth Uterine septum

Interventions

1. Hysteroscopic septal resection 2. No intervention All patients will be followed up in the same way.

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Uterine septum diagnosed with three-dimensional ultrasound 2. Aged at least 18 years old 3. Desire to conceive 4. History of one or more miscarriages (regardless of previous viable or live births 5. No previous surgery on the uterus or endometrial cavity 6. Body-mass index of 40 kg/m² or less Added 06/08/2015: 7. Women with infertility

Exclusion criteria

Exclusion criteria: 1. Other uterine anomalies apart from septum 2. Age younger than 18 years old 3. Not planning to become pregnant 4. Currently pregnant

Design outcomes

Primary

Measure	Time frame
Live birth surviving until discharge from hospital	—

Secondary

Measure	Time frame
1. Uterine perforation 2. Fluid overload 3. Endometritis 4. Bleeding 5. Incomplete resection 6. Synechiae or adhesions 7. Clinical pregnancy rate 8. Miscarriage (first or second trimester) 9. Premature delivery (<34 weeks and <37 weeks) 10. Ectopic pregnancy 11. Uterine rupture 12. Delivery (vaginal, elective or emergency) 13. Post-partum haemorrhage (1500 mL) 14. Placenta praevia 15. Morbidly adherent placenta	—

Measure

Time frame

1. Uterine perforation 2. Fluid overload 3. Endometritis 4. Bleeding 5. Incomplete resection 6. Synechiae or adhesions 7. Clinical pregnancy rate 8. Miscarriage (first or second trimester) 9. Premature delivery (<34 weeks and <37 weeks) 10. Ectopic pregnancy 11. Uterine rupture 12. Delivery (vaginal, elective or emergency) 13. Post-partum haemorrhage (1500 mL) 14. Placenta praevia 15. Morbidly adherent placenta

—

Countries

United Kingdom

Contacts

Public ContactMatthew Prior

Outcome results

None listed

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