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OpenTrials
Completed

NCT Number: NCT04098289

Preterm Delivery After Septum Resection

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female primary infertility
  • Singleton pregnancies

Exclusion criteria

  • Female secondary infertility
  • Multiple pregnancies

Treatment and study plan

Hysteroscopic septum resection

Procedure

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

In vitro fertilization

Procedure

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).

Primary outcomes

  1. Preterm delivery rate

    Time frame: Through study completion, an average of 5 year

    Percentage of delivery that occurs before the start of the 37th week of pregnancy.

Sponsors and collaborators

Lead sponsor

Università degli Studi dell'Insubria

Other

Collaborators

  • University of Ljubljana

Registry information

Official study title

Effect of Hysteroscopic Septum Resection on Preterm Birth Rate in Singleton Pregnancies After Primary Infertility Treatment

Acronym: PLEASURE-1

Important dates

Study start
2012
Primary completion
2015
Study completion
2019
First posted
Sep 23, 2019
Registry last updated
Apr 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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