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Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy

Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03218059
Enrollment
100
Registered
2017-07-14
Start date
2017-07-15
Completion date
2018-12-31
Last updated
2017-07-14

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

Conditions

Cesarean Scar Pregnancy, Menstruation

Keywords

Cesarean Scar Pregnancy

Brief summary

Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D&C in the treatment of CSP.

Interventions

PROCEDUREMethotrexate Combined With Transvaginal Surgery

The methods of treatment of CSP

Sponsors

Shanghai First Maternity and Infant Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

Increased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.

Exclusion criteria

All enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.

Design outcomes

Primary

MeasureTime frameDescription
Duration of menstruation by questionnairesix months after treatmentDuration of menstruation
Endocrine level by blood examinationsix months after treatmentFSH in IU/L
Volume of menstruation by questionnairesix months after treatmentin pictorial blood loss score

Secondary

MeasureTime frameDescription
The length of the CSD by MRIsix months after treatmentmillimeter
The depth of the CSD by MRIsix months after treatmentmillimeter

Countries

China

Contacts

Primary ContactXipeng Wang
xipengwang@hotmail.com0086-13817806602
Backup ContactHuihui Chen
huihui78505@hotmail.com0086-13916278505

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026