Rare Diseases

All Conditions

Cervical Intraepithelial Neoplasia

1. The study will include 150 women of reproductive age (21-45 years) who wished to have future pregnancies and had cervical biopsy or Pap test, without any other cervical procedure, in the same calendar year.
2. a 3-years follow-up for pregnancy outcome
3. Transvaginal ultrasound for pretreatment cervical dimensions/volume

1. The study will include 150 women of reproductive age (21-45 years) planning for excisional treatment for CIN who wished to have future pregnancies. Women are included irrespective of their parity, previous obstetric history, and CIN grade.
2. a 3-years follow-up for pregnancy outcome
3. Transvaginal ultrasound for pretreatment cervical dimensions/volume
4. Transvaginal ultrasound for posttreatment cervical dimensions/volume in the follow-up visit
5. Estimation of cone dimensions/volume
6. Calculation of the proportion of volume/length excised

Lina Hu

Hu Li

Li Hu

Shufang Chang

This study aims to assess how the proportion of the cervical volume/length removed during treatment for cervical intraepithelial neoplasia (CIN) varies and whether this correlates to the pregnancy duration at delivery

The high peak age of the Cervical intraepithelial neoplasia (CIN)patients was from 25 to 35 years old, which is the best women of childbearing age, Standard treatment for CIN is called Loop electrosurgical excision procedure (LEEP),but the inappropriate conization may damage the cervical function leading to infertility, abortion, preterm delivery and dystocia. Therefore, reasonable and standard conization is very important for treating and preventing the complication. The International Federation of Cervical Pathology and Colposcopy(IFCPC) advocates the length of cervical conization should be decided by the type of cervical transformation zone, however, the cervical lengths in female are different leading to the same cervical conization lengths cause the diverse influences on the cervical function.Therefore, individualized cervical conization therapies are very needed，At present, there are still lack of objective data about cervical morphology of women at childbearing age,besides the effects of cervical morphological changes caused by LEEP on pregnancy and childbirth has not been reported.

Our hypothesis is that the proportion of the cervical tissue removed is likely to influence both cervical healing and the cervical volume following surgery and as a result the risk of prematurity in subsequent pregnancies. The present prospective study investigates the variation in the proportion of the cervix removed during excisional treatment and provides pilot data on pregnancy outcomes in a sample population for which the dimensions and proportions of the cervical tissue excised are assessed at the time of treatment.

Cervical Morphological Changes on Pregnancy Outcome

The Effect of Cervical Morphological Changes on Pregnancy Outcome After Loop Electrosurgical Excision Procedure

The dimensions and volume of the cervix before treatment are calculated by two-dimensional transvaginal sonography (2D-TVS)

The dimensions of the cone are measured with a measuring tape and a ruler before formalin fixation. The measurements included the length/depth, and the anteroposterior,transverse, and lateral diameters. A fluid filled volumetric cylindrical vial (tube) are subsequently used to measure the cone volume with the fluid displacement technique

Assessment of the cervical dimensions and the cervical volume is repeated 1,3,6,12 months post-treatment follow-up visit, using the same imaging technique as that used pretreatment

In the event of a pregnancy, the prenatal management and outcomes are recorded. More specifically, it is recorded whether interventions such as cervical length ultrasound, cervical cerclage, or progesterone are used. The duration of pregnancy at delivery, the birth weight, and other obstetric outcomes and complications are recorded.

The Second Affiliated Hospital of Chongqing Medical University

Symptoms and General Pathology

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Hypoglycemic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Metformin

Androgens

Folic Acid

Vitamin B Complex

Folinic Acid

Folate

Vitamin B9

Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.

Placebo

Sven M Carlsen, MD, PhD

To investigate the effect of metformin on pregnancy complications and pregnancy outcome in the II. and III. trimester of pregnancy in women with polycystic ovary syndrome.

Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study

(µmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)

Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. measured by a double antibody technique on an Elecsys 2010 analyser (Roche Diagnostics GmbH, Germany) using reagents and calibrators supplied by the manufacturer

(nmol/l) Analysed in serum, from venous blood samples from the mother and venous and arterial umbilical cord blood (separately) collected within 1 h of birth. Measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)

Calculated as total testosterone divided by SHBG and multiplied by a factor of 100. SHBG measured using a competitive immunoassay on an Immulite 2000 analyser using the reagents and calibrators supplied by the manufacturer (Diagnostic Products Corp., USA)

Gestational diabetes (GDM) defined according to World Health Organization (1998) criteria, i.e. 2 h plasma glucose values ≥7.8 mmol/l during an Oral Glucose Tolerance Test (OGTT) with 75 g. Uncomplicated GDM treated with dietary advice only was not ranked among the complications in this study. Pre-eclampsia defined as a blood pressure ≥140/90mmHg with concomitant albuminuria ≥0.3 g/24 h measured on two separate occasions after gestational week 20. Premature delivery was defined as delivery before gestational week 37 + 0 according to an estimated date of delivery, based on mid-trimester ultrasound scan

Gestational length (cm) measured at birth

Head circumference (cm) measured at birth.

Umbilical artery pH measured in umbilical artery blood, immediately after delivery on a Rapidlab 248pH/Blood Gas Analyzer, using reagents and calibrators supplied by the manufacturer (Bayer Corp., USA)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cervical Morphological Changes on Pregnancy Outcome	NCT03242746	Pregnancy Outco...		21 Years - 45 Years	The Second Affiliated Hospital of Chongqing Medical University
Cervical Morphological Changes on Pregnancy Outcome	NCT03242746	Pregnancy Outco...		21 Years - 45 Years	The Second Affiliated Hospital of Chongqing Medical University
Metformin Treatment of Pregnant Women With Polycystic Ovary Syndrome: a Pilot Study	NCT03259919	Polycystic Ovar...	Metformin Placebo	18 Years - 40 Years	Norwegian University of Science and Technology

Spots Global Cancer Trial Database for pregnancy outcome