Preterm Delivery After Septum Resection

Completed

• Conditions: Septum; Uterus; Infertility, Female; Preterm Birth
• Interventions: Procedure: Hysteroscopic septum resection; Procedure: In vitro fertilization

• Registration Number: NCT04098289
• Lead Sponsor: Università degli Studi dell'Insubria

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Primary Completion: 2015-12
• Study First Submitted: 2019-09-19
• Study First Submitted QC: 2019-09-19
• Study First Posted: 2019-09-23
• Study Completion: 2019-12
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 420

Inclusion Criteria

• Female primary infertility
• Singleton pregnancies

Exclusion Criteria

• Female secondary infertility
• Multiple pregnancies

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hysteroscopic septum resection without in vitro fertilization	Hysteroscopic septum resection	Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with natural conception (without the use of in vitro fertilization techniques).
Hysteroscopic septum resection with in vitro fertilization	In vitro fertilization	Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.
Hysteroscopic septum resection with in vitro fertilization	Hysteroscopic septum resection	Primary infertile women who underwent hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.
In vitro fertilization, without hysteroscopic septum resection	In vitro fertilization	Primary infertile women who did not undergo hysteroscopic septum resection and obtained the first pregnancy with the use of in vitro fertilization techniques.

Primary Outcome Measures

Name	Time	Method
Preterm delivery rate	Through study completion, an average of 5 year	Percentage of delivery that occurs before the start of the 37th week of pregnancy.