Preterm Delivery After Septum Resection

Preterm Birth Clinical Trial

— PLEASURE-1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04098289
• Other study ID #: PLEASURE-1
• Status: Completed
• Start date: July 2012
• Est. completion date: December 2019

Study information

• Verified date: April 2021
• Source: Università degli Studi dell'Insubria
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: December 2019
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Female primary infertility

• Singleton pregnancies

Exclusion Criteria:

• Female secondary infertility

• Multiple pregnancies

Related Conditions & MeSH terms

• Infertility
• Infertility, Female
• Premature Birth
• Preterm Birth
• Septum; Uterus

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Università degli Studi dell'Insubria	University of Ljubljana

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preterm delivery rate	Percentage of delivery that occurs before the start of the 37th week of pregnancy.	Through study completion, an average of 5 year