Scar; Previous Cesarean Section Clinical Trial
Official title:
Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the
fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous
cesarean section.
A recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of
options represents a real challenge for the health care provider. The choice may be made
among expectant management, medical treatment, local treatment and surgical approach, also
combined together. There is insufficient evidence to recommend any one specific intervention
over another for caesarean scar pregnancy. Future studies are needed to define the optimal
management of pregnancy for caesarean section scars.
Thus, we aim to compare the success rate of two different treatment of CSP: the medical
management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D&E)
compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.
Status | Recruiting |
Enrollment | 54 |
Est. completion date | January 15, 2022 |
Est. primary completion date | December 15, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Singleton gestations; - 18 years to 50 years; - Diagnosis of CSP; - Gestational age = 8 weeks and 6 days; - Therapy with systemic Methotrexate 2-dose; - Thickness of myometrial layer =2 mm. Exclusion Criteria: - Diagnosis of cervical pregnancy, aborting intrauterine pregnancy, or any other anomalous implantation site; - Gestational age >8 weeks and 6 days; - Heavy vaginal bleeding at the time of randomization; - Women who did not received Methotrexate or received a single dose or a local dose; - Thickness of myometrial layer <2 mm - Women who are unconscious, ill, mentally handicapped; - Women under the age of 18 years or over the age of 50 years. |
Country | Name | City | State |
---|---|---|---|
Italy | Gabriele Saccone | Napoli |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate of treatment protocols, | defined as no further treatment required until the complete resolution of the scar pregnancy. | resolution of scar pregnancy, day 7 | |
Secondary | Further treatment required until the complete resolution of the scar pregnancy | Further treatment required until the complete resolution of the CSP (repeat administration of methotrexate (MTX) and/or other surgical procedures), | resolution of scar pregnancy, day 7 | |
Secondary | histerectomy | histerectomy | resolution of scar pregnancy, day 7 | |
Secondary | Maternal transfusion | Maternal transfusion | resolution of scar pregnancy, day 7 |
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