The Journal of Obstetrics and Gynaecology of India
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VOL. 74 NUMBER 1 January-February  2024

Cesarean Scar Pregnancy: Results of Treatment Using a Double-Balloon Cervical Ripening Catheter

Azadeh Tarafdari1 · Alireza Hadizadeh2 · Elnaz Irandoost1 · Sedigheh Borna1 · Azin Ghamari3 · Fahimeh Ghotbizadeh Vahdani1

Azadeh Tarafdari: Associate professor and consultant of Obstetrics and Gynaecology at Tehran University of Medical Sciences; Alireza Hadizadeh: post-doctoral research fellow at Tehran University of Medical Sciences; Elnaz Irandoost: Obstetrician and Gynaecologist at Tehran University of Medical Sciences; Sedigheh Borna: professor and consultant of Obstetrics and Gynaecology at Tehran University of Medical Sciences; Azin Ghamari: postdoctoral research fellow at Tehran University of Medical Sciences; Fahimeh Ghotbizadeh-vahdani: Associate professor and consultant of Obstetrics and Gynaecology at Tehran University of Medical Sciences.

Fahimeh Ghotbizadeh

Vahdani fghotbi@yahoo.com

1 Department of Obstetrics and Gynecology, Imam Khomeini Hospital Complex, Tehran University of Medical Sciences, Tehran 14197‑33147, Iran

2 Research Center for Advanced Technologies in Cardiovascular Medicine, Cardiovascular Diseases Research Center Institute, Tehran University of Medical Sciences, Tehran, Iran

3 Growth and Development Research Center, Children’s Medical Center, Tehran University of Medical Sciences, Tehran, Iran

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Background Being considered a life-threatening condition, cesarean scar pregnancy (CSP) leads to loss of fertility, severe bleeding, and even maternal mortality. We intended to assess the effect of double-balloon cervical ripening catheter insertion on CSP termination before nine weeks of gestation.

Method All participants were diagnosed CSP by abdominal and transvaginal ultrasound. The cases were treated with a sterile, double-balloon cervical ripening catheter inserted with real-time transabdominal ultrasound guidance and removed three days later. The control group consisted of patients treated with systemic methotrexate with or without fetal reduction.

Results Thirty-five patients were eligible for double-balloon ripening and 32 for MTX therapy; the treatment in cases failed in five of the patients. Success rate difference between two methods was insignificant (Pearson Chi-square: 0.383, p-value: 0.536). There were significant differences regarding the time to normal menstruation (OR: 1.303) and the thickness of the myometrium after surgery (OR: 4.721), but there was no significant difference in the time resolve of either β-HCG or residue of pregnancy.

Conclusion Double-balloon cervical ripening insertion yields acceptable results for terminating CSP. This strategy does not cause bleeding and even prevents it with its tamponade properties. Additionally, this treatment is minimally invasive simple with low morbidity.

Keywords : Cesarean section · Cesarean scar pregnancy · Double-balloon insertion · Fertility

Being considered as a major life-threatening condition, cesarean scar pregnancy (CSP) refers to the implantation and growth of the gestational sac in the fibrous scar tissue of the prior cesarean section (CS) (1). The CS delivery rate is increasing worldwide, especially among the developing countries, with an annual incidence of 18.5 million cases (2). Hence, it is not surprising to detect the rising CSP rate since its first description four decades ago (3). Although the accurate incidence of CSP is unclear, the estimated incidence of CSP is reported to range from 1 in 1800 to 1 in 2216 pregnancies due to its underdiagnosis, with the rate of 6.1% of all ectopic pregnancies among women with prior history of CS in the USA (4).

The increasing prevalence of CS and its associated complications, most significantly CSP and placenta accretanecessitates obstetricians to be more familiar with this condition, to have early diagnosis, and to recognize the best treatment with the least complications. The diagnosis is based on ultrasound findings, including empty uterine and cervical cavity, and gestational sac implantation in a cesarean scar (1). Expectant management is not globally accepted as it causes high maternal morbidity and mortality. There is a wide variety of treatment strategies for pregnancy termination including medical, radiological and surgical interventions, alone or in combination. However, in case of unwise treatment, many of the known treatments lead to loss of fertility, severe bleeding, and even, maternal mortality. A treatment strategy relies on various determinants such as gestational age, pregnancy viability, family planning, and the surgeon’s skill. In treatment, the primary goal is to maintain maternal health and the secondary goal is to maintain fertility (5).

Several studies have highlighted the application of a double- balloon catheter to control postpartum hemorrhage (6). The application of such a catheter has also been considered for CSP termination. This method is minimally invasive, is well tolerated by patients, prevents hemorrhagic complications, maintains fertility, and does not require additional invasive interventions in most cases. It is noteworthy that the application of a double-balloon catheter is well-recognized among obstetricians as a conventional method for cervical ripening in labor induction. To the best of our knowledge, since the introduction of the method by Timor‐Tritsch and his coworkers, few studies have assessed its efficacy for CSP termination (7–9). The current study began concurrent with other studies after the publication by Timor‐Tritsch secondary to the significance of his results, added to the literature regarding the feasibility and effectiveness of doubleballoon cervical ripening catheter insertion in terminating CSPs before 9 weeks of gestation, and presented associated complications and challenges that may be encountered by obstetricians. Furthermore, we also compared the results with the conventional method of systemic methotrexate therapy which might precipitate the chances of adverse drug reactions.

Declarations
Conflict of interest
The authors declare no conflicts of interest.

Ethical consideration This study was approved by the Research Deputy and the Ethics Committee of the Tehran University of Medical Sciences (Reference number: IR. TUMS.IKHC.REC.1397.312) and conducted in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and all subsequent revisions.

Informed consent A written informed consent form was obtained from all the participants

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