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NCT Number: NCT07703917

TENS for Postpartum Uterine Pain During Breastfeeding

This clinical study is designed to evaluate whether Transcutaneous Electrical Nerve Stimulation (TENS) is an effective, non-drug method to relieve postpartum uterine pain during breastfeeding in multiparous women (women who have given birth multiple times). Breastfeeding in the first 48 hours after delivery often triggers strong, painful uterine contractions due to the natural release of oxytocin. While standard care typically relies on pain-relief medications, this study investigates if TENS, a safe, low-cost device that sends gentle electrical impulses through small skin patches, can significantly reduce this pain and decrease the need for systemic medications. Participants will be randomly assigned to either receive standard postpartum pain medications or use a TENS device during two consecutive breastfeeding sessions. Researchers will measure and compare the peak pain levels between both groups using a standard 0 to 10 pain scale. The aim is examining whether TENS will significantly reduce postpartum uterine pain during breastfeeding and decrease medication use compared with standard care.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Family Hospital

Nazareth, Israel

About this study

This randomized, controlled, parallel-group clinical trial will evaluate the efficacy and safety of Transcutaneous Electrical Nerve Stimulation (TENS) as a non-pharmacological intervention for reducing oxytocin-induced postpartum uterine contractions during breastfeeding. The study cohort consists of 124 eligible multiparous women (2 or more previous births) admitted to the Department of Obstetrics and Gynecology at Holy Family Hospital in Nazareth, Israel, within 48 hours following a term, singleton, vaginal delivery. Following the acquisition of written informed consent, participants will be randomized at a 1:1 ratio into either the TENS study group or the standard care control group. The experimental protocol will be integrated into two consecutive breastfeeding sessions. Body positioning will be strictly standardized across both cohorts. TENS Study Group (Intervention): Prior to the second consecutive breastfeeding session, four conductive gel electrodes will be affixed to the participant. Two electrodes will be positioned bilaterally over the lower abdomen, directly overlying the uterus. The remaining two electrodes will be placed in parallel in the S2-S4 dermatomal region to target the spinal nerve pathways receiving nociceptive afferent input from the uterus and cervix. Active stimulation will commence a few minutes prior to breastfeeding and continue for the entire duration of the feed. The TENS device will deliver a 100-Hz current and 75 msec pulse for 40 min, using 20-60 milliamps of intensity.

To establish a baseline pain score, the first evaluated breastfeeding session for this group will be conducted without TENS application, followed by active TENS during the second session. Control Group Protocol: Participants assigned to the control group will receive standard postpartum care and will undergo the identical data collection schedule across two consecutive breastfeeding sessions, but without any TENS electrode placement or electrical stimulation.

For both study arms, pharmacological analgesia will remain accessible as needed per existing institutional department protocols, and all instances of medication administration (including specific agent, timing, and dosage) will be precisely documented. Uterine pain scores will be captured across both groups at three identical time points during each of the two consecutive breastfeeding sessions: Maternal discomfort associated directly with the physical application or sensation of the TENS unit will be separately quantified.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Maternal Age above 18
  • Term delivery (37 weeks or more)
  • Vaginal delivery within the past 48 hours.
  • Multiparous women (2 or more previous births)
  • Delivery of a singleton
  • Have the well to breastfeed

Exclusion criteria

  • Contraindication to TENS (pacemaker, epilepsy, active infection, uncontrolled hyper / hypotension.)
  • Chronic analgesia use
  • Severe complications requiring intervention (severe PPH) or intensive care
  • Skin lesions, infections, or scars at proposed electrode sites
  • Neonatal intensive care unit admission

Treatment and study plan

Transcutaneous Electrical Nerve Stimulation (TENS)

Device

Bilateral application of four skin electrodes using conductive gel. Two electrodes will be placed on the lower abdomen over the uterus, and two will be placed in parallel in the S2-S4 sacral region. The digital sensory-motor TENS device will be programmed to generate a 100-Hz current and 75 msec pulse for 40 min, using 20-60 mA of intensity. Stimulation begins a few minutes before breastfeeding and continues throughout the 40-minute session.

Primary outcomes

  1. Peak VAS pain score during breastfeeding in the second session

    Time frame: During the second breastfeeding session, within the first 48 hours postpartum

    The maximum VAS score recorded will be compared between groups. Postpartum uterine pain during breastfeeding will be evaluated using a standard Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

Secondary outcomes

  1. Consumption of Pharmacological Analgesics

    Time frame: First 48 hours postpartum

    Total dosage (mg) of pain relief medications consumed by the participant within the first 48 hours postpartum.

  2. Peak VAS pain score during breastfeeding in the second compared with the first sessions.

    Time frame: During two consecutive breastfeeding sessions within the first 48 hours postpartum

    The maximum VAS score in the first and second session will be recorded and compared within the same group. Postpartum uterine pain during breastfeeding will be evaluated using a standard Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (worst imaginable pain).

  3. Duration of breastfeeding sessions.

    Time frame: In the two consecutive breastfeeding sessions within the first 48 hours postpartum

    The time, in minutes, that the woman is able to continue breastfeeding.

  4. Adverse effects related to TENS use

    Time frame: During the second session, within the first 48 hours postpartum

    Local adverse effects related to TENS in the intervention group.

  5. Maternal discomfort

    Time frame: First 48 hours postpartum

    The women will also be asked to estimate the discomfort of the TENS use using a 5-point verbal scale from no discomfort (0) to worst possible discomfort (5).

  6. Formula use

    Time frame: First 48 hours postpartum

    Use of any infant formula in addition to breastfeeding

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa Bayatra, MD

CONTACT

[email protected]

97246508900

RAED SALIM, PROF

CONTACT

[email protected]

97246508900

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

Transcutaneous Electrical Nerve Stimulation for Treating Postpartum Uterine Pain During Breastfeeding in Multiparous Women: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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