Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03506204
Other study ID # JS-1549
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 10, 2018
Est. completion date December 31, 2020

Study information

Verified date April 2018
Source Peking Union Medical College Hospital
Contact Zhijing Sun, MD
Phone 13651314354
Email sunzhj2001@sina.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

It is a prospective cohort study.The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle. The pelvic floor muscle function is evaluated at 6 weeks,3 months and 12 months after delivery.


Description:

The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle.Evaluation of pelvic floor function is performed at 6 weeks, 3 months, 12 months after delivery. The modified Oxford Grading Scale and Levator ani testing are used to quantify PFM strength through vaginal palpation. Pelvic floor muscles strength, endurance, repetition,vaginal contraction pressure and the knack test are evaluated using a neuromuscular stimulation therapy system of PHENIX (Company: Vivaltis -Electronic Concept Lignon Innovation, Montpellier, France).


Recruitment information / eligibility

Status Recruiting
Enrollment 3120
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria:

1. Women who give birth for the first time (Including vaginal delivery and cesarean section)

2. Term birth(37-42 weeks)

3. Single birth

4. Aged from 18 to 50

5. Plan to live locally for extended periods of time

Exclusion Criteria:

1. A history of incontinence before pregnancy

2. A history of fecal incontinence before pregnancy

3. Pelvic organ prolapse before pregnancy (prolapse out of the hymen )

4. A history of abortion or induced labour over 16 weeks of pregnancy

5. Multiple pregnancy

6. The weight of the newborn is less than 2500g or more than 4000g

7. Precipitate labour

8. Operative vaginal delivery(obstetric forceps or vacuum extraction)

9. Laceration of perineum at least level III

10. Request for pelvic floor rehabilitation exercise(patients who have entered the group can not train the pelvic floor muscle)

11. Obesity (BMI before pregnancy over 25, BMI=weight (kg) / height square (m2) )

12. Asthma

13. Long-term abdominal pressure(chronic cough for more than 1 months ,long-term constipation ect.)

14. Diabetes

15. Cotugno's disease

16. A history of pelvic floor surgery in the previous years

Study Design


Locations

Country Name City State
China Peking Union Medical College Hospital, Chinese Academy of Medicine Sciences Beijing Beiing

Sponsors (26)

Lead Sponsor Collaborator
Peking Union Medical College Hospital Changzhi Maternity & Child Health Hospital, Chengdu Women's and Children's Central Hospital, Dalian Gynaecology and Obstetrics Hospital, Dalian Municipal Women and Children's Medical Center, Fourth Hospital of Shijiazhuang City, Henan Provincial Hospital, Huaian Maternal and Child Health Care Hospital, Hubei Maternal and Child Health Hospital, Hubei Shiyan People's Hospital, Hunan Provincial Maternal and Child Health Care Hospital, Liuzhou Maternity and Child Healthcare Hospital, Maternal and Child Health Care Hospital of Xinjiang Uygur Autonomous Region, Maternity and Child Care Center of QinHuangDao City, Maternity and Child Health Hospital of Changsha, Maternity and Child Health Hospital of Dali, Second Affiliated Hospital of Soochow University, Second Affiliated Hospital of Wenzhou Medical University, Shandong Provincial Maternal and Child Health Care Hospital, Shen-Zhen City Maternity and Child Healthcare Hospital, Shenzhen Luohu District Maternity And Child Healthcare Hospital, Shunyi Maternal and Children's Hospital of Beijing Children's Hospital, The First Affiliated Hospital with Nanjing Medical University, The First Hospital of Hebei Medical University, The People's Hospital of Leshan, Zhongshan City People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Maximum vaginal contraction pressure it is measured by manometry, range(80-150cmH2O). The higher values represent better outcomes. Change from Baseline Maximum Vaginal Contraction Pressure in a year after delivery
Secondary Pelvic floor muscle strength The modified Oxford Grading Scale is used to quantify PFM strength through vaginal palpation.range(0-5).The higher values represent better outcomes. change from baseline in a year after delivery
Secondary Pelvic floor muscle strength(repetition) Levator ani testing is used to quantify PFM strength.range(0-5).The higher values represent better outcomes. change from baseline in a year after delivery
Secondary Pelvic floor muscle contraction edurance muscle contractions maintained for 0 s are defined as grade 0, 1 s as grade I, 2 s as grade II, 3 s as grade III, 4 s as grade IV, and 5 s or longer as grade V. Normal muscles can maintain the contraction for 5 s.range(0-5s).The higher values represent better outcomes. change from baseline in a year after delivery
Secondary the knack test a voluntary PFM contraction before or during coughing.That the contraction could be performed represents normal. change from baseline in a year after delivery
Secondary vaginal rest pressure measure when no vaginal contraction by manometry. range(25-50 cmH2O). the lower and the higher values represent abnormal outcomes. change from baseline in a year after delivery
Secondary Condition of stress urinary incontinence Ingelman-Sundberg classification is used according to the clinical symptoms of urinary incontinence, divided into mild, moderate and severe. change from baseline in a year after delivery
Secondary pelvic organ prolapse quantification(POP-Q) POP-Q is measured when maximum valsalva.range(0-4). stage 0 represents normal. change from baseline in a year after delivery
See also
  Status Clinical Trial Phase
Completed NCT05655364 - Development of a Breastfeeding Supportive Mobile Application N/A
Not yet recruiting NCT06336434 - CREATE - Cabotegravir & Rilpivirine Antiretroviral Therapy in Pregnancy Phase 1/Phase 2
Recruiting NCT05073224 - Muscle Function After Childbirth N/A
Completed NCT04820296 - Effects of Solution-Oriented Approach on Psychosocial Health, Fear of Childbirth and Postnatal Senses of Security N/A
Completed NCT03733405 - Postpartum Care Timing: A Randomized Trial N/A
Completed NCT04005391 - Home-based Delivery of the Contraceptive Implant in Postpartum Guatemalan Women N/A
Withdrawn NCT04265690 - A Multi-Component Nutrition Program for Pregnant and Parenting Teens N/A
Recruiting NCT06284278 - Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain N/A
Completed NCT04536597 - Quince Seed Jelly and Breast Milk on Nipple Fissures N/A
Completed NCT03595696 - Core Strengthening for DRA in Postpartum Women N/A
Completed NCT04480931 - Pilot Testing a Mobile App to Designed to Increase Physical Activity Among Pregnant and Postpartum Women N/A
Not yet recruiting NCT03521284 - Health Education in the Perinatal Period
Completed NCT02432573 - Timing of Morning Rounds for Postpartum Hospitalized Women N/A
Completed NCT01968330 - Postpartum Weight Loss and Sleep Amongst Obese Women N/A
Completed NCT03146000 - Lidocaine-prilocaine Cream Versus Rectal Meloxicam on Relief of Post-episiotomy Pain Phase 3
Completed NCT03686319 - The Effect of Reflexology on Lactation and Postpartum Comfort for Cesarean-delivery Primiparous Mothers N/A
Completed NCT01274637 - PROSPER: PostpaRtum PrOphylaxiS for PE Randomized Control Trial Pilot Phase 3
Completed NCT05800548 - Health Literacy of Postpartum Women and Family Planing
Completed NCT05021302 - Differences in the Effectiveness of Electromagnetic Stimulation Therapy and Kegel Exercises Based on Compliance, Subjective - Objective Symptoms and Pelvic Floor Muscle Strength in Postpartum Stress Urinary Incontinence N/A
Active, not recruiting NCT05537259 - BUMPP: A Study to Better Understand Mood During the Perinatal Period