Surgery Alone Versus Methotrexate Before Surgery in Cesarean Scar Pregnancy

Surgery Alone Versus Methotrexate Before Surgery in Cases of First Trimester Cesarean Scar Pregnancy: a Randomized Controlled Trial

There are no universal treatment guidelines available. The ultimate purpose of the management of CSP is to simultaneously remove the pregnancy and successfully preserve the woman's fertility (Gonzalez & Tulandi, 2017). A variety of medical and surgical treatment modalities for CSP have been reported; however, most of these are based on low-level evidence(Sun et al., 2019).

Study Overview

• Status: Unknown
• Conditions: Cesarean Scar Pregnancy
• Intervention / Treatment: Drug: Methotrexate

Detailed Description

This will be a randomized clinical trial to evaluate the effect of administration of methotrexate before surgery in reducing bleeding, injury to bladder and ureter, operative time and removing of CSP mass.This will be in comparison to surgery alone in cases of first trimester cesarean scar pregnancy

• Study Type: Interventional
• Enrollment (Anticipated): 56
• Phase: Phase 4

Contacts and Locations

Study Locations

• Egypt
  • Dakahliya
    • Mansoura, Dakahliya, Egypt
      • Recruiting
      • Mansoura University
      • Contact: Maher Elgaly, MD,MRCOG

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:•

• Gestational age before 13 w
• Past history of 1 or more CS
• Presence of GS implanted on cesareans scar

Exclusion Criteria:

• Presence of severe vaginal bleeding (emergency)
• Previous history of uterine surgery other than CS
• The whole mass is interior and the bulge is more in the cavity
• Bleeding disorder
• Patient not candidate for methotrexate (Positive fetal heart pulsation,
• Patient refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: surgery; Valid consent; Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ); Laparotomy transverse incision (pfannenstiel incision); Exploration of the abdominal cavity; Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.; Surgical repair of the uterine incision, and the abdomen	Drug: Methotrexate; giving methotrexate at least 1 w week before surgery; Other Names: unitrexate
ACTIVE_COMPARATOR: methotrexate before surgery; Valid consent; patient will receive 50 mgm /m2 of methtrexate after full investigation ( CBC, serum creatinie, AlT, AST), 1 week before surgery.; Anathesia , (regional may br converted into general ). IV antibiotic ( cefotaxime 1 gm I.V ); Laparotomy transverse incision (pfannenstiel incision); Exploration of the abdominal cavity; Identification of the uterus, dissection of the bladder, incision of the uterus and excision of the CSP mass.; Surgical repair of the uterine incision, and the abdomen	Drug: Methotrexate; giving methotrexate at least 1 w week before surgery; Other Names: unitrexate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated blood loss intraoperative	the amount of blood in soaked towels and vacuum aspiration	intraoperative blood loss

Secondary Outcome Measures

Outcome Measure	Time Frame
need further management	1 month
• Rate of urological injury	immediatly and 1 week post operative
• Rate of readmission, relaparotomy	with in 1 month

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Principal Investigator: Maher Elgaly, Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2019
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): December 1, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (ACTUAL): May 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2020
• Last Update Submitted That Met QC Criteria: May 4, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: cesarean scar pregnancy, methotrexate, miscarriage, ectopic pregnancy
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Dermatologic Agents; Reproductive Control Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Folic Acid Antagonists; Methotrexate
• Other Study ID Numbers: R.19.10.639.R1.R2.R3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No