Antispasmodic Drug for Diagnosis Proximal Tubal Occlusion on Hysterosalpingography

NCT02618785 | Completed DMC

• 1 other identifier: 562441242
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

This study finds premedication Hyoscine-N-butylbromide before hysterosalpingography have a potential effect for diagnosis of proximal tubal obstruction in infertile women. The investigators did a double-blind, randomized placebo-controlled trial

Conditions

Tubal Obstruction

Keywords

Hysterosalpingography; antispasmodic drug; infertile women

Outcome Measures

Primary Outcomes (1)

• number result diagnosis of proximal tubal occlusion

  To evaluate rate diagnosis of proximal tubal occlusion compare between Hyoscine group and placebo group before HSG.

  up to 24 weeks

Secondary Outcomes (2)

• number of true occlusion or false occlusion

  up to 24 weeks

• number of participants with treatment-related adverse effects of drug and procedure

  up to 24 weeks

Study Arms (2)

Hyoscine

EXPERIMENTAL

The experiment group receive Hyoscine 10 mg 2 tablets by mouth before hysterosalpingography procedure

Procedure: hysterosalpingography

Placebo

PLACEBO COMPARATOR

The control group receive placebo by mouth before hysterosalpingography procedure

Procedure: hysterosalpingography

Interventions

hysterosalpingography PROCEDURE

Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. A tenaculum was applied to the anterior cervix to help for stabilization and counter-traction. Then insert a sterile Rubin's cannula into the cervix uteri. A scout radiograph of the pelvis was obtained with the catheter in place before contrast material was instilled. After that the water soluble contrast media was slowly instilled through the cannula appropriate volume range 10-15 ml., with fluoroscopic images obtained intermittently to evaluate the uterus, fallopian tubes and tubal patency

Also known as: HSG

Hyoscine; Placebo

Eligibility Criteria

• Age: 19 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The infertile women who indicated for investigation hysterosalpingography were enrolled.

You may not qualify if:

• Known sensitivity to Hyoscine or contrast media
• Genital tract infection
• Suspected pregnancy
• Abnormal uterine bleeding

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University

Hat Yai, Changwat Songkhla, 90112, Thailand

Location

Related Publications (13)

• Hindocha A, Beere L, O'Flynn H, Watson A, Ahmad G. Pain relief in hysterosalpingography. Cochrane Database Syst Rev. 2015 Sep 20;2015(9):CD006106. doi: 10.1002/14651858.CD006106.pub3.

  PMID: 26387564 BACKGROUND

• Practice Committee of the American Society for Reproductive Medicine. Diagnostic evaluation of the infertile female: a committee opinion. Fertil Steril. 2015 Jun;103(6):e44-50. doi: 10.1016/j.fertnstert.2015.03.019. Epub 2015 Apr 30.

  PMID: 25936238 BACKGROUND

• Steinkeler JA, Woodfield CA, Lazarus E, Hillstrom MM. Female infertility: a systematic approach to radiologic imaging and diagnosis. Radiographics. 2009 Sep-Oct;29(5):1353-70. doi: 10.1148/rg.295095047.

  PMID: 19755600 BACKGROUND

• Hajishafiha M, Zobairi T, Zanjani VR, Ghasemi-Rad M, Yekta Z, Mladkova N. Diagnostic value of sonohysterography in the determination of fallopian tube patency as an initial step of routine infertility assessment. J Ultrasound Med. 2009 Dec;28(12):1671-7. doi: 10.7863/jum.2009.28.12.1671.

  PMID: 19933481 BACKGROUND

• Kodaman PH, Arici A, Seli E. Evidence-based diagnosis and management of tubal factor infertility. Curr Opin Obstet Gynecol. 2004 Jun;16(3):221-9. doi: 10.1097/00001703-200406000-00004.

  PMID: 15129051 BACKGROUND

• Moore DE. Pain associated with hysterosalpingography: Ethiodol versus Salpix media. Fertil Steril. 1982 Nov;38(5):629-31. doi: 10.1016/s0015-0282(16)46647-1. No abstract available.

  PMID: 6290276 BACKGROUND

• Marjoribanks J, Ayeleke RO, Farquhar C, Proctor M. Nonsteroidal anti-inflammatory drugs for dysmenorrhoea. Cochrane Database Syst Rev. 2015 Jul 30;2015(7):CD001751. doi: 10.1002/14651858.CD001751.pub3.

  PMID: 26224322 BACKGROUND

• Kemp JH. "Buscopan" in spasmodic dysmenorrhoea. Curr Med Res Opin. 1972;1(1):19-25. doi: 10.1185/03007997209111141. No abstract available.

  PMID: 4589399 BACKGROUND

• Rohwer AC, Khondowe O, Young T. Antispasmodics for labour. Cochrane Database Syst Rev. 2013 Jun 5;2013(6):CD009243. doi: 10.1002/14651858.CD009243.pub3.

  PMID: 23737030 BACKGROUND

• Alper MM, Garner PR, Spence JE. Hyoscine butylbromide to relieve utero-tubal obstruction at hysterosalpingography. Br J Radiol. 1985 Sep;58(693):915. doi: 10.1259/0007-1285-58-693-915-a. No abstract available.

  PMID: 3842296 BACKGROUND

• Moro F, Selvaggi L, Sagnella F, Morciano A, Martinez D, Gangale MF, Ciardulli A, Palla C, Uras ML, De Feo E, Boccia S, Tropea A, Lanzone A, Apa R. Could antispasmodic drug reduce pain during hysterosalpingo-contrast sonography (HyCoSy) in infertile patients? A randomized double-blind clinical trial. Ultrasound Obstet Gynecol. 2012 Mar;39(3):260-5. doi: 10.1002/uog.11089.

  PMID: 22223598 BACKGROUND

• Jareethum R, Suksompong S, Petyim S, Prechapanich J, Laokirkkiat P, Choavaratana R. Efficacy of mefenamic acid and hyoscine for pain relief during saline infusion sonohysterography in infertile women: a double blind randomized controlled trial. Eur J Obstet Gynecol Reprod Biol. 2011 Apr;155(2):193-8. doi: 10.1016/j.ejogrb.2010.11.021. Epub 2010 Dec 30.

  PMID: 21194827 BACKGROUND

• Jitchanwichai A, Soonthornpun K. Effect of Premedication Hyoscine-N-Butylbromide before Hysterosalpingography for Diagnosis of Proximal Tubal Obstruction in Infertile Women: A Randomized Double-Blind Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):110-116. doi: 10.1016/j.jmig.2018.03.034. Epub 2018 Apr 24.

  PMID: 29702271 DERIVED

MeSH Terms

Conditions

Fallopian Tube Diseases

Condition Hierarchy (Ancestors)

Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Akarawit Jitchanwicahi, MD

  Department of Obstetrics and Gynecology, Faculty of Medicine, Prince of Songkla University, Songkhla 90112, Thailand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Obstertrics and Gynecology department

Study Record Dates

• First Submitted: November 21, 2015
• First Posted: December 1, 2015
• Study Start: June 1, 2016
• Primary Completion: March 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 18, 2017

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)