Clinical trial NCT04098289: Preterm Delivery After Septum Resection
Official title: Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septum; Uterus
Infertility, Female
Preterm Birth
Keywords: Hysteroscopy
Metroplasty
Primary infertility
Preterm delivery
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
Collaborators: name: University of Ljubljana
First posted: 2019-09-23
Enrollment: 420
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women affected by primary infertility who obtained the first ongoing pregnancy with (cases) or without (controls) previous hysteroscopic septum resection, with or without in vitro fertilization.

Brief summary: Uterine septum is the most common congenital uterine malformation. It accounts for approximately 35% of all uterine malformations, while the frequency of uterine malformations in the general fertile population is estimated to be between 1% and 4%.

The presence of a uterine septum is associated with subfertility and a high incidence of obstetric complications, such as spontaneous abortion, 3-fold increase in preterm premature rupture of the membranes (PROM), 6-fold increase in preterm delivery, malpresentation at delivery, caesarean section, and increased perinatal morbidity and mortality.

Some studies have found that surgical resection of the uterine septum improves pregnancy outcomes and significantly reduces the risk of preterm delivery. Therefore, the risk for a short-term adverse outcome and long-term sequelae due to preterm delivery such as intraventricular hemorrhage, necrotizing enterocolitis, sepsis, patent ductus arteriosus, retinopathy, deafness, chronic lung disease, cerebral palsy, perinatal death, and impaired mental development in women with uterine septum could be lowered by performing a relatively simple and safe hysteroscopic septum resection (HSR).

However, there are two major concerns regarding HSR: cervical incompetence due to excessive dilatation during hysteroscopy and the rare yet serious complication of uterine rupture in subsequent pregnancy or delivery.

Considering these elements, the aim of this study will be to evaluate the rate of preterm delivery in singleton pregnancy comparing primary infertile women who underwent HSR and who did not undergo the same procedure, with our without in vitro fertilization.


Eligibility criteria: Inclusion Criteria:

* Female primary infertility
* Singleton pregnancies

Exclusion Criteria:

* Female secondary infertility
* Multiple pregnancies

Primary outcomes:
measure: Preterm delivery rate
timeFrame: Through study completion, an average of 5 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Ljubljana
name: Helena Ban Frangež, M.D.
role: STUDY_DIRECTOR
affiliation: University of Ljubljana
name: Jana Miklavcic, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Università degli Studi dell'Insubria
name: Antonio Simone Laganà, M.D.
role: STUDY_CHAIR
References: