Preterm Delivery After Septum Resection

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.

Conditions

• Septum; Uterus
• Infertility, Female
• Preterm Birth

Interventions

PROCEDURE

Hysteroscopic septum resection

Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.

PROCEDURE

In vitro fertilization

Fertilization of oocytes with the spermatozoa of the partner, after induction of ovulation and capacitation of the sperm, using fertilization in vitro and embryo transfer (FIVET) or intracytoplasmic sperm injection (ICSI).

Sponsors & Collaborators

• University of Ljubljana

  collaborator OTHER

• Università degli Studi dell'Insubria

  lead OTHER

Principal Investigators

• Helena Ban Frangež, M.D. · University of Ljubljana

• Jana Miklavcic, M.D. · University of Ljubljana

• Antonio Simone Laganà, M.D. · Università degli Studi dell'Insubria

Eligibility

Min Age

18 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-07-31

Primary Completion

2015-12-31

Completion

2019-12-31