← Human Trials & Peer-Reviewed Studies

The Relationship Between Oxytocin Massage in Mothers With Insufficient Milk Production in the Early Postpartum Period and Breastfeeding Self-Efficacy and Milk Let-down Reflex: A Randomized Controlled Study

Plain-language guide to NCT07609693: not phased randomized trial of Oxytocin, 128 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT07609693
Phase
not phased
Status
recruiting participants
Start
2026-05-12
Completion (planned or actual)
2026-05-12
Participants
128 (estimated)
Design
randomized, open label (everyone knows who gets what), treatment
Conditions studied
Lactation Disorders
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

Insufficient milk supply is a common issue often linked to maternal stress, which can inhibit oxytocin release and negatively impact the milk ejection reflex and the mother's confidence in breastfeeding.

It had two arms (groups): Oxytocin Massage Group (experimental) and Routine Care Group (no intervention).

Mothers assigned to this group will receive a single session of oxytocin massage prior to breastfeeding. The massage will be applied by the researcher to the thoracic paravertebral region (T4-T6 level) using rhythmic and circular movements for 20-30 minutes, in accordance with a standardized protocol.

Mothers assigned to this group will not receive any additional experimental interventions. They will only receive the institution's routine standard postpartum hospital care.

The registry classes the interventions as other.

More on the Plan

Breastfeeding is a fundamental public health intervention in protecting maternal and neonatal health, and the early postpartum period is particularly critical for the initiation and maintenance of lactation (WHO, 2023).

However, physiological, psychological, and environmental factors experienced in the early postpartum period can negatively impact breastfeeding success.

During this period, the mother's hormonal balance, birth experience, fatigue level, and emotional adaptation are among the main factors determining the quality of the breastfeeding process.

One of the most frequently reported problems by mothers in the early postpartum period is insufficient milk supply or perceived insufficient milk (Brown et al., 2022).

Who Took Part

128 planned participants were the target.

It was open to women only aged from 18 years with no upper age limit.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Being 18 years of age or older. Being in the early postpartum period (within the first 24-48 hours after birth). Having had a single, live birth via vaginal delivery or cesarean section. Having a term (≥37 weeks) and healthy baby. Being in the same room as the baby (rooming-in practice).

The full record lists 9 inclusion and 9 exclusion criteria; among the exclusions: having given birth preterm (\<37 weeks); having given birth as a result of a multiple pregnancy; having been admitted to the neonatal intensive care unit (nicu).

How the Study Was Run

Design: randomized, parallel-group and open-label.

Because people in this Oxytocin study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2026-05-12 with completion listed for 2026-05-12.

It ran at 1 site in Turkey (Türkiye).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 1 secondary outcome, for example Perception of Insufficient Milk Supply Questionnaire.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Oxytocin in 128 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.