NCT03805945

Brief Summary

The purpose of this study was to investigate whether dexmedetomidine used in the perioperative period of elective cesarean section can improve maternal mood, improve analgesic effect, improve maternal recovery quality, and then make the breastfeeding better.At the same time, this experiment attempts to explore the optimal dose of dexmedetomidine to produce the above effect.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2019

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 16, 2019

Completed
5 months until next milestone

Study Start

First participant enrolled

June 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 2, 2019

Completed
Last Updated

December 3, 2019

Status Verified

January 1, 2019

Enrollment Period

6 months

First QC Date

January 13, 2019

Last Update Submit

December 2, 2019

Conditions

Cesarean Section

Keywords

Cesarean SectionDexmedetomidineBreast FeedingRecovery quality

Outcome Measures

Primary Outcomes (2)

  • Postpartum depression at sixth week after caesarean section

    The Edinburgh Postnatal Depression Scale(EPDS) was used to determine the presence of postpartum depression through an electronic questionnaire in the sixth week after delivery. The Edinburgh Postnatal Depression Scale(EPDS) consists of 10 items. According to the severity of the symptoms, each item is scored in 4 levels (0, 1, 2, 3 points) with a cumulative maximum score of 30 points.In order to reduce the rate of missed diagnosis, we refer to the previous literature and use 10 points as the diagnostic threshold for postpartum depression. A score of 10 or more is considered as postpartum depression.

    6th week postpartum

  • Self-reported exclusive breastfeeding at sixth week after caesarean section

    Self-reported exclusive breastfeeding at sixth week postpartum by telephone follow-up.If exclusive breastfeeding is discontinued, obtain the point of discontinuation.

    6th week postpartum

Secondary Outcomes (4)

  • Hospital Anxiety and Depression Scale(HADS) score

    Preoperative, 1st day and 2nd day postpartum

  • LATCH breastfeeding assessments

    1st day postpartum

  • VAS score after cesarean section

    6,12,24 and 48 hours after cesarean section

  • Quality-of-recovery score

    Preoperative, 1st day and 2nd day postpartum

Study Arms (2)

dexmedetomidine group

EXPERIMENTAL

After umbilical cord was cut, a loading dose of dexmedetomidine was pumped at 0.5ug/kg within 10min, followed by a further infusion of dexmedetomidine at 0.5ug /kg/h until the end of the surgery.Then connected with patient-controlled intravenous analgesia pump (dexmedetomidine 2ug/kg + sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).

Drug: dexmedetomidine group

control group

PLACEBO COMPARATOR

Continuous infusion of saline after the umbilical cord was cut until the end of the operation.Then connected with patient-controlled intravenous analgesia pump (sufentanil 1.5ug/kg + dolasetron 25mg/100ml saline).

Drug: control group

Interventions

dexmedetomidine groupDRUG

After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).

Also known as: D group
dexmedetomidine group
control groupDRUG

After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.

Also known as: C group
control group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsParturients are females.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA class I or II
  • BMI≦35kg/m2
  • Greater than 37 weeks gestation
  • Expressed a desire to breastfeed for a least 3 months postpartum
  • Elective cesarean section

You may not qualify if:

  • Intraspinal anesthesia contraindication
  • Twin or fetal Intrauterine distress
  • Preoperative history of application of analgesia or sedative drug
  • Severe cardiac and pulmonary dysfunction
  • History of neurological and psychiatric diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, 221000, China

Location

Related Publications (11)

  • Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.

    PMID: 26869575RESULT

  • Xu H, Ding Y, Ma Y, Xin X, Zhang D. Cesarean section and risk of postpartum depression: A meta-analysis. J Psychosom Res. 2017 Jun;97:118-126. doi: 10.1016/j.jpsychores.2017.04.016. Epub 2017 Apr 24.

    PMID: 28606491RESULT

  • Silva CS, Lima MC, Sequeira-de-Andrade LAS, Oliveira JS, Monteiro JS, Lima NMS, Santos RMAB, Lira PIC. Association between postpartum depression and the practice of exclusive breastfeeding in the first three months of life. J Pediatr (Rio J). 2017 Jul-Aug;93(4):356-364. doi: 10.1016/j.jped.2016.08.005. Epub 2016 Dec 26.

    PMID: 28034730RESULT

  • Hobbs AJ, Mannion CA, McDonald SW, Brockway M, Tough SC. The impact of caesarean section on breastfeeding initiation, duration and difficulties in the first four months postpartum. BMC Pregnancy Childbirth. 2016 Apr 26;16:90. doi: 10.1186/s12884-016-0876-1.

    PMID: 27118118RESULT

  • Nie Y, Liu Y, Luo Q, Huang S. Effect of dexmedetomidine combined with sufentanil for post-caesarean section intravenous analgesia: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2014 Apr;31(4):197-203. doi: 10.1097/EJA.0000000000000011.

    PMID: 24463478RESULT

  • Yoshimura M, Kunisawa T, Suno M, Sugawara A, Kurosawa A, Nakanishi R, Aoki K, Toriumi T. Intravenous dexmedetomidine for cesarean delivery and its concentration in colostrum. Int J Obstet Anesth. 2017 Nov;32:28-32. doi: 10.1016/j.ijoa.2017.05.002. Epub 2017 May 10.

    PMID: 28687146RESULT

  • Schnabel A, Meyer-Friessem CH, Reichl SU, Zahn PK, Pogatzki-Zahn EM. Is intraoperative dexmedetomidine a new option for postoperative pain treatment? A meta-analysis of randomized controlled trials. Pain. 2013 Jul;154(7):1140-9. doi: 10.1016/j.pain.2013.03.029. Epub 2013 Mar 27.

    PMID: 23706726RESULT

  • Ciechanowicz S, Setty T, Robson E, Sathasivam C, Chazapis M, Dick J, Carvalho B, Sultan P. Development and evaluation of an obstetric quality-of-recovery score (ObsQoR-11) after elective Caesarean delivery. Br J Anaesth. 2019 Jan;122(1):69-78. doi: 10.1016/j.bja.2018.06.011. Epub 2018 Jul 31.

    PMID: 30579408RESULT

  • Funai Y, Pickering AE, Uta D, Nishikawa K, Mori T, Asada A, Imoto K, Furue H. Systemic dexmedetomidine augments inhibitory synaptic transmission in the superficial dorsal horn through activation of descending noradrenergic control: an in vivo patch-clamp analysis of analgesic mechanisms. Pain. 2014 Mar;155(3):617-628. doi: 10.1016/j.pain.2013.12.018. Epub 2013 Dec 16.

    PMID: 24355412RESULT

  • Lau Y, Wang Y, Yin L, Chan KS, Guo X. Validation of the Mainland Chinese version of the Edinburgh Postnatal Depression Scale in Chengdu mothers. Int J Nurs Stud. 2010 Sep;47(9):1139-51. doi: 10.1016/j.ijnurstu.2010.02.005. Epub 2010 Mar 12.

    PMID: 20219196RESULT

  • Wang Y, Fang X, Liu C, Ma X, Song Y, Yan M. Impact of Intraoperative Infusion and Postoperative PCIA of Dexmedetomidine on Early Breastfeeding After Elective Cesarean Section: A Randomized Double-Blind Controlled Trial. Drug Des Devel Ther. 2020 Mar 11;14:1083-1093. doi: 10.2147/DDDT.S241153. eCollection 2020.

    PMID: 32210537DERIVED

MeSH Terms

Conditions

Breast Feeding

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ming Yan, M.D/Ph.D

    The Affiliated Hospital of Xuzhou Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 13, 2019

First Posted

January 16, 2019

Study Start

June 1, 2019

Primary Completion

December 2, 2019

Study Completion

December 2, 2019

Last Updated

December 3, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)